215 Iso 13485 Jobs - Page 9

Bachelor s degree in Electronics Engineering or a related technical field (Master s preferred). Experience: 15+ years of experience in quality management, preferably in electronics manufacturing. Strong knowledge of electronic components, PCBA manufacturing, and testing processes. Experience with regulatory and quality standards (ISO 9001, IPC standards, etc.). Certified Six Sigma Black Belt or equivalent is a plus. Excellent leadership, communication, and problem-solving skills Role: Quality Head Job Profile: Quality Strategy & Leadership Develop and execute the overall quality strategy aligned with company goals. Lead the quality function across multiple departments including manufacturing, engineering, supply chain, and customer support. Build and manage a high-performing quality team. Quality Assurance & Compliance Ensure compliance with relevant quality standards (e.g., ISO 9001, ISO 13485, IATF 16949, IPC-A-610, RoHS, REACH). Maintain QMS (Quality Management System) documentation and ensure audit readiness. Lead internal and external audits (certification bodies, customers, suppliers). Quality Control & Manufacturing Support Oversee inspection processes (incoming, in-process, and final inspection). Analyse quality metrics (e.g., PPM, yield, scrap rates) and implement corrective actions. Collaborate with production and engineering teams to resolve quality issues on the shop floor. Supplier Quality Management Evaluate and qualify suppliers; implement supplier audits. Drive supplier performance improvements and corrective action plans. Customer Focus Handle customer quality complaints and ensure timely resolution. Lead root cause analysis and implementation of CAPA (Corrective and Preventive Actions). Ensure high customer satisfaction related to product quality. Continuous Improvement Drive continuous improvement using tools like Six Sigma, Lean, 8D, FMEA, SPC, and 5 Whys.

A Day in the Life Responsibilities may include the following and other duties may be assigned Experience in distributed product development, team building skills, talent management, conflict resolution, budget management and global stake holder management are critical to the role. Manage a cross functional (SW, FW, Systems) engineering technical team size of 20 or more. Provide a blend of people management and technical savviness. Should have worked on development of products and on successful delivery of solutions. Deep understanding in product development processes & regulations (IEC 60601, IEC 62304, ISO 13485, ISO 14971) Design controls for medical device development in order to coach and guide the technical leads is expected. Identify the needs and prepare capabilities in the cross functional areas, SW development and verification and validation areas to foster full turnkey solution to the business. Provide a deep understanding of the embedded and application SW development processes (Agile, waterfall methodology) and help establish SW metrics & recommended the processes for the team. Research and maintain solution architecture, technical design, tools and technology stack and related system and drive proof of concept efforts in MEIC. Must be able to support the global team in organic, blended, inorganic product development projects. Support the technology road map of Medical Devices by proactively pitching for technology development and turnkey projects. Support Regional Growth plans and product requirements to boost tailored product for the regions Establish and remain educated on the relevant technology standards (DICOM, HL7, 62304, ISO 11073 etc.) Develop junior members by coaching, empowering, reviewing results, both in technical areas and in soft skills. Identify solution knowledge gaps within MEIC in Medical Devices solutions and prepare plans to address them ( strategic alliances and self-managed teams ) Required Knowledge and Experience Experience of minimum of 17+ years in product development with at least a min of 10+ years in medical device development & verification. Good hands on experience in systems engineering, software development C#/C++ and real time systems. Knowledge of Python programming/scripts Knowledgeable in design controls for medical devices (related to CFR 820.30) 510K, IEC 62304 & other relevant standards. Product development experience for local markets ( in country for country) would certainly be a plus. Strong proven capability & track record in developing product applications and strong knowledge in device communication & diagnostics, database systems and latest communication protocols. Hands-on application development (right from requirement analysis to deployment) and management of sizeable teams in FW, HW, & SW application development & verification activities. Strong Leadership expectations traits for mid-level leaders (internal candidates only) Bachelor s degree either in Computer Science, Computer Engineering or Electronics & communication Engineering. A Master s degree preferred. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The Advanced Technician QC is responsible for Reporting directly to the supervisor of quality control, this position will be responsible for performing the day today activities in Quality Control function at Beckman Coulter Bangalore Development Centre. Ensure Compliance of quality control procedures and activities to 21 CFR 820, ISO 13485, ISO 9001, MDSAP, Beckman Coulter corporate Quality system requirements. This position reports to the Lead FG QC and is part of the Quality and Regulatory Affairs-Quality Control located in IND - Bangalore North - Beckman Coulter India Private Limited and will be an on-site role. In this role, you will have the opportunity to: Conducts routine analysis of raw materials, in-process and finished goods under supervision and according to Standard Operating Procedures (SOPs) and Compiles data for documentation of test procedures and prepares reports. Write or revise standard quality control operating procedures and supply quality control data necessary for regulatory submissions. Participates and performs investigation with respect to QC testing performed. Ensure that lab cleanliness and safety standards are maintained. The essential requirements of the job include: Master s degree with 3+ years with or without related experience. Must have critical thinking skills and good judgment working in an independent environment Good communication skills (verbal / written / presentation / relationship building) with ability to work collaboratively. It would be a plus if you also possess previous experience in: Handled Flow cytometer Handled HPLC Handled QMS like Change controls, Deviations, CAPA.

The Development Engineer, Firmware at HemoCue is responsible for documentation and test of design changes within the Sustaining Engineering department, mainly firmware changes. This position is part of the R&D-team located in Bangalore and will be on-site. At HemoCue, our vision is to do things easier, to do things better, and to do them right. You will be a part of the Sustaining Engineering and report to the Director of Sustaining Engineering, (located in at headquarter in Sweden). You will be responsible for planning, design, implementation, documentation, and test of software modules. If you thrive in a fast-paced environment, enjoy working independently but also cross-functionally and want to work to build a world-class R&D organization read on. In this role, you will have the opportunity to: Perform product support activities for current products, primary instrument activities Cross-functional work with operations department and/or subcontractor by solving problems, coordinating, verifying and approving changes to HemoCue products Execute and/or participate in product lifecycle activities, such as CAPAs, engineering change orders, cost down activities and general sustaining engineering activities The essential requirements of the job include: University degree: Master of Science, Bachelor of Science or Engineering or equivalent work experience within Software and at least 3 years of work experience Knowledge of software development tools, design patterns and programming paradigms. Experience of C and C++ development on embedded systems (ARM microcontrollers). Knowledge of analog and digital electronics Your main communication language will be English Knowledge about ISO 13485, QSReg and Design Control It would be a plus if you also possess previous experience in: Experience from product development of medical devices Experience from design changes for medical devices Cybersecurity

The Development engineer, Electronic at HemoCue is responsible for finding replacement components, update the design documents and together with the team test the design change within the Sustaining Engineering department. This position is part of the R&D team located in Bangalore and will be on-site. At HemoCue, our vision is to do things easier, to do things better, and to do them right. You will be a part of the Sustaining Engineering team and report to the Director of Sustaining Engineering (located in at headquarter in Sweden). You will be responsible for planning, design, implementation and documentation of obsolete electronic components. If you thrive in a fast-paced environment, enjoy working independently but also cross-functionally and want to work to build a world-class R&D organization read on. In this role, you will have the opportunity to: Perform product support activities for current products, primary instrument activities Cross-functional work with operations department and/or subcontractor by solving problems, coordinating and approving changes to HemoCue products Execute and/or participate in product lifecycle activities, such as CAPAs, engineering change orders, cost down activities and general sustaining engineering activities The essential requirements of the job include: University degree: Master of Science, Bachelor of Science or Engineering or equivalent work experience within electronics and at least 3 years of work experience Knowledge of analog and digital electronics Experience from working with electronics schematics & PCB s and using tools such as Altium Designer Your main communication language will be English Knowledge about ISO 13485, QSReg and Design Control It would be a plus if you also possess previous experience in: Experience from product development of medical devices Experience from design changes for medical devices

Beckman Coulter LS Beckman Coulter Life Sciences is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives. Position Summary and Overview: Responsible for managing the sites Non-conformance (NC) and deviation processes. This includes reviewing and approving NC records, containing non-conforming material, conducting trend analysis, managing related CAPAs, and driving root cause investigations. The role maintains compliant Quality Management System (QMS) procedures for NCs and supports internal and external audits and inspections. Essential Duties and Responsibilities: Reviews and approves all aspects of Non-conformance (NC) records, including initial accuracy, dispositions, investigations, impact assessments, categorization, closure, and due date extensions, ensuring all actions are accurately recorded as per the procedural requirements. Ensures appropriate physical segregation and labeling of nonconforming material in the designated quarantine area. Performs trend analysis on Non-conformances to identify improvement opportunities and manages the system for Corrective Actions (CAPAs) initiated through NCs. Participates in root cause investigations for Non-conformances and other quality issues and presents findings to management. Responsible for the overall handling and management of product-related non-conformances and planned deviations within the site. Maintains and monitors the Quality Management System, including site-specific and global Non-conformance procedures, ensuring full compliance with requirements, regulations, and standards. Supports audit and inspection activities, including preparation, liaison with auditors, and resolution of findings, and performs other related duties as required. Qualification and Experience: Minimum Requirements: Bachelors or master s degree in biology, Engineering or related disciplines Minimum of 5-7 years related experience in quality assurance and/or regulatory affairs Knowledge of ISO 13485, GMP and GLP requirements would be advantageous Experience with handling non-conforming products and other Quality Management System processes. Demonstrated experience in flow cytometry is crucial and will be highly advantageous. Required Competencies: Exceptional communication skills (verbal / written / presentation / relationship building) with ability to work collaboratively with cross-functional project teams and regulators Ability to drive results, foster teamwork, handle pressure, and provide feedback. Must be able to demonstrate skills in root cause investigation and problem solving. Organized, detail-oriented with impeccable integrity. High level of initiative, self-motivation, and energy.

The Senior Software Engineer is responsible for designing and developing the automated tests using the in-house test automation framework and improving the overall test coverage to support new product development and design changes of Total Lab Automation product. This position reports to the Engineering Manager System Verification & Validation and is part of the System R&D Team located in India Development Center, Bengaluru and will be an on-site role. In this role, you will have the opportunity to: Create and maintain robust automated tests and implement the strategies defined for test automation. Improve and maintain the stability of the automated tests pipelines. Bring improvements to the test automation framework based on the industry s best practices to enhance the overall test coverage. Collaborate with developers, verification engineers, product owner s, system engineers and QA team members to ensure test coverage and quality. Continuously developing skills and contribute to team improvement. The essential requirements of the job include: Bachelor s degree in computer science engineering or a related field with 5+ years of experience in testing medical device products in a regulated environment, with a strong focus on test automation. Strong experience in designing/developing test scripts using C# programming language and worked on automation tools like Selenium, Appium, WinAppDriver, SpecFlow (BDD) and others. Proficient in practically applying OOPS concepts and uses logic and rigorous problem-solving skills to resolve problems and drives to effective solutions. Strong understanding and proficient in API testing Demonstrates a proactive debugging mindset by isolating issues through step-by-step analysis, log investigation, and root cause identification towards ensuring faster resolution and improved test reliability. It would be a plus if you also possess previous experience in: ISTQB foundation in Software Testing or equivalent competence to undertake the qualification. Experience of medical device quality standards such as IEC 62304, ISO 13485 and ISO 14971 Beckman Coulter Diagnostics, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info .

The Senior Manufacturing Quality Engineer for Beckman Coulter Diagnostics is responsible for: Liaise with the reagent contract manufacturer and represent Beckman Coulter Quality in the interaction with the contract manufacturer and is responsible for the generation, analysis and reporting of quality metrics to relevant personnel and to ensure on-going improvement programs are put in place. Lead cross functional teams providing Quality guidance and guide in the determination of appropriate NC root cause analysis and implementation of effective corrective actions. Responsible for the Rework process, ensuring relevant documentation is prepared, reviewed and approved as per company procedures as well as completing Acceptable Quality Level (AQL) inspections prior to product disposition. Execute the Stop Ship process for finished product released to the market, in the Oracle system, ensuring process is compliant to relevant company procedures and perform CAPA (corrective and preventive action) activities and document in the CAPA system if required. Review & Approve document Change Controls (CCFs) and Equipment Change Controls (ECCs) ensuring Good Manufacturing Practices are maintained and comply with company procedures. Author relevant procedures, Review/Approve documentation (e.g. protocols, reports) ensuring compliance to applicable procedures and provide Quality expertise during the product life cycle. Review & Approve Certificate of Analysis(COA) for the finished goods. This position is part of the International Quality Operations located at Ernakulam, Kerala, India and will be on-site at the OEM site. At Beckman Coulter, our mission is to Relentlessly Reimagine Healthcare, One Diagnosis at a Time. You will be a part of the Quality, Regulatory and Clinical Affairs and report to the Senior Manager Quality and Regulatory Affairs, India Quality Operations responsible for Beckman Coulter Reagent Manufacturing Quality in India. If you thrive in a multifunctional role and want to work to build a world-class Quality organization read on. In this role, you will have the opportunity to: Define programs for manufacturing quality improvement Execute and participate in audits(supplier audits, external audits etc) Liaise with Tech-ops and R&D departments on validation requirements for new and current products and processes as well as with the regional and global Q&RA organization to support the growth of and ensure alignment with BEC global policies and procedures The essential requirements of the job include: Minimum of 10 years experience in manufacturing quality in either medical devices or pharma industry or with background in biochemistry production in a highly regulated environment with Bachelors in Biochemistry or equivalent Excellent organizational and communication skills and fluent in English language is required Solid working knowledge of EU, FDA and related regulations including QSR s, (FDA 21 CFR 820), ISO 13485 or ISO 9001, IVD s, It would be a plus if you also possess previous experience in: Experienced in quality management methods (8D, Six Sigma, Statistical Tools, FMEA) Experienced in working within multi-functional, multi-regional teams

Experience : minimum 3 years Job Type : Full-time Job Summary: We are seeking a detail-oriented and knowledgeable Regulatory Compliance Officer to ensure our medical devices meet all applicable regulatory requirements and standards. The ideal candidate will play a critical role in overseeing compliance activities, preparing regulatory submissions, and collaborating with cross-functional teams to maintain product and process integrity throughout the device lifecycle. Key Responsibilities: Monitor and interpret evolving regulations, standards, and guidance relevant to medical devices (e.g., FDA, ISO 13485, MDR). Ensure organizational practices and product development comply with national and international regulations. Prepare, review, and submit regulatory documentation including device registrations, licenses, and clinical trial applications. Act as a liaison with regulatory authorities and provide updates to internal teams. Maintain thorough documentation of all regulatory activities, including correspondence, submissions, and audit records. Identify potential compliance risks and implement mitigation strategies. Conduct internal training sessions on regulatory standards and updates. Participate in internal and external audits; ensure implementation of corrective actions. Manage post-market surveillance activities, including adverse event reporting and trend analysis. Design and implement regulatory compliance programs and standard operating procedures (SOPs). Required Skills and Competencies: Strong analytical and problem-solving abilities to interpret regulatory requirements. Excellent communication skills for effective interaction with regulatory agencies and internal stakeholders. High attention to detail and strong organizational skills. In-depth knowledge of regulatory standards and frameworks (e.g., US FDA 21 CFR, ISO 13485, EU MDR). Ability to manage multiple projects simultaneously and meet strict deadlines. Strong understanding of medical device lifecycle, development, and manufacturing processes. Proficient in MS Office and regulatory document management tools. Qualifications: Bachelor s degree in Life Sciences, Engineering, Pharmacy, or related discipline. Experience in the medical device industry, specifically in regulatory affairs or quality assurance. Demonstrated understanding of regulatory submission processes and documentation. Certifications in regulatory affairs (e.g., RAC) are a plus.

Department: Quality Assurance / EngineeringLocation: ChandigarhExperience: 5 to 8 yearsReports To: Director of the company Job Summary: We are looking for a dedicated and technically Quality Head Healthcare Equipment - SYSMED Quality Head Healthcare Equipment Department: Quality Assurance / Engineering Location: Chandigarh Experience: 5 to 8 years Reports To: Director of the company Job Summary: We are looking for a dedicated and technically skilled Quality Head with 5 to 8 years of experience in the healthcare equipment industry. The ideal candidate must have hands-on experience with ventilators, patient monitors, and other critical care hospital equipment. This role involves performing stringent quality inspections and ensuring that all medical devices meet regulatory, functional, and safety standards before reaching healthcare facilities. Key Responsibilities: Perform quality inspections and functional tests on ventilators, patient monitors, syringe pumps, and other medical devices. Ensure all equipment adheres to industry standards such as ISO 13485, IEC 60601, and BIS compliance. Document quality inspection findings and maintain accurate QC records and test reports. Identify and report non-conformities and collaborate with production and service teams to resolve issues. Conduct periodic equipment calibration, testing, and validation. Ensure labeling, packaging, and documentation align with medical device compliance protocols. Support internal audits and assist during external regulatory inspections. Suggest improvements for testing procedures and product quality. Required Skills and Qualifications: Diploma or Degree in Biomedical Engineering, Electronics, or related technical field. Minimum 5 years to maximum 8 years of relevant experience in quality checking or service of medical devices. Good knowledge of hospital equipment, especially ventilators and patient monitors. Understanding of medical equipment standards, safety procedures, and quality systems. Skilled in using electrical and mechanical testing tools. Strong attention to detail, documentation skills, and problem-solving mindset. Preferred: Prior experience working in a medical device manufacturing company. Certification in Medical Device Quality Systems (optional but advantageous). Familiarity with Government e-Marketplace (GeM) compliance and hospital tenders is a plus.

Job Title Mechanical Designer Job Description #LIPHILIN Job Description In this role, you have the opportunity to Manage high impact, complex sustaining & transfer projects that enables Philips to reduce risk, improve profitability, align with Philips strategic supply base and optimize supply chain flexibility. The primary function within this role is to execute engineering activities through the course of fast-paced, high quality transfer and sustaining projects. You will be responsible for driving meaningful and innovative product development, generating ideas/concepts in feature development to improve quality and reduce cost, as well as performing the role of a technical lead in taking the product development through manufacturing release while transferring products between suppliers and manage sustaining of different devices by following PDLM-MLD process. Your responsibilities: Design and detail components and systems, including conducting predictive analysis and calculations. Select materials and processes appropriate for those designs Obtain parts and create prototypes. Write test protocols, conduct tests, analyze data, and report results. Successfully interact with associates in other departments, such as Manufacturing Operations, Procurement, and engineering staff, to achieve project and product objectives. Develop new test methods and tools as necessary. Specify, acquire, and maintain lab equipment. Operate lab instruments such as micrometer, tachometer, manometers, flow meters, tensile and compression testers, data acquisition systems, environmental chambers, and computer programs. Be a highly motivated, self-disciplined, open-minded individual possessing hands-on skills. Requirements detailing, design specification preparation, implementation, test, and integration of Unit per the higher-level Requirement and - Design specifications/architectures. Ensures the mutual consistency and efficient integration of the separate modules in modular, easy-to-maintain units that meet the product specification. Understands and communicates the consequences of their design on the architecture. Determines the Unit interfaces (HW/SW) in close consultation with relevant disciplines. Ensures that there is proper documentation for his/her design. Keeps abreast of technical developments in own field through study of the literature and technical contacts and propagates it. Defines, execute, and take the lead in concept and feasibility studies with a limited scope to investigate the usability of new technologies. Contributes to technology roadmaps and other strategic-related activities. Takes technological or process-related improvements initiatives within the scope of at least the mechanical development group. Contributes to the Work Breakdown Structure/ the planning process of his/her area. Draws up personal schedule and reports on progress. Inspires team members to get the job done. Performs work in line with the processes that have been agreed in the department. You are a part of A high-impact, global organization within Philips that works across all modalities The Supplier Transfer Excellence Team (STET). STET has been established as an entrepreneurial organization that focuses on fast-paced, high-quality portfolio transfers within the Philips global supply base to mitigate risk & maximize profitability. To succeed in this role, you should be having BE/ B Tech (Mech) (8 to 10 years exp) 8-10 years of relevant experience in design & development of electro-mechanical sub-systems & systems. Strong communication and collaborative abilities proactively seeks out expertise and advice and input from others in a collaborative team-environment, Project Management skills (Dealing with suppliers) In-depth knowledge and 8+ years of experience in the development of mechanical design Experience in creating design concepts and mechanical designs of complex parts or assemblies. Strong knowledge and experience in CAD/CAE. such Creo, D&T,, LCM- Life cycle management. Experience in metal or plastic crafts (drilling, milling, etc.) would be appreciated Experience in PDM/ PLM (Windchill, Teamcenter etc) Good knowledge and experience with gate staged development governance, ideally familiar with ISO 13485 or FDA-regulated development processes. knowledge of medical requirements and regulatory standards is beneficial (such as IEC 60601-1) Capability to interact in cross-functional teams Outstanding commitment, being innovative and adaptive Medical Device Experience- Nice to have How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company s facilities. Field roles are most effectively done outside of the company s main facilities, generally at the customers or suppliers locations. Indicate if this role is an office/field/onsite role.

A Day in the Life This position will be responsible for establishing/enabling the vitality and growth for the portfolio by creating strategic partnerships and effective governance through efficient use of Medtronic s resources and tools. The individual will work closely with the cross-functional platform leader & team teams in MEIC and GBUs. The individual will lead the Strategy roadmap for the feature/component of the overall solution, partnering with other members on the PO & Marketing Team Members. This position will play a vital role in growing business engagements & enabling value-add by focusing on patient and clinician needs. Responsibilities may include the following and other duties may be assigned Seasoned Product Owner with Product Management experience Act as the leader of the project team, driving end-to-end execution and accountability. Accountable for a products impact on customers, users Leads or leverages cross-functional stakeholders to evaluate, develop, and manage new product development and ongoing lifecycle management of products and processes Assesses product issues and develops resolutions to meet market requirements, quality, and client-satisfaction goals and objectives Partners closely and serves as a liaison between Product Management and Technical Execution Team (System Engineer, Architect, UI/UX Designers, DevOps, Testers, Scrum Master, etc.) Develop mechanisms to understand project progress and for intervention and problem solving with product managers, Scrum master, and other key stakeholders Gathers requirements, works on requirements planning, requirements elicitation, and requirements management to ensure they meet the demands of market requirements and key stakeholders Communicates with stakeholders, obtains stakeholder engagement to ensure the end products or processes will solve the business problems Leads a shared understanding of What we should build and be able to justify Why through discussion and documentation Extends shared understanding with the scrum teams who will be executing Plays a critical role in sprint demos by utilizing it as a feedback loop for validation of intended impact Makes the decision on when enough value has been created to close user stories and ready for release Point person to ensure all deliverables are prioritized Required Knowledge and Experience Minimum 14 + years of relevant experience with 5+ years in Product Owner in Web/ Mobile Space. Awareness of Industry tools for VOC. Requirement prioritization, Roadmap & long-term solution Strategy Good to have experience in medical devices or other regulated industries. Strong understanding of agile development principles and practices, including Scrum and Kanban Excellent communication, collaboration, analytical and problem-solving skills Ability to work effectively with cross-functional teams and stakeholders Familiarity with agile tools such as JIRA or similar software tools Experience with product management and product development processes, including user research, market analysis, and product road mapping Software Development experience in Agile or Waterfall methodologies especially worked on SDLC. Excellent interpersonal and influence management skills including evidence of managing multi-discipline teams Technical Understanding and Business Acumen Knowledge of Product Life Cycle Familiarity with FDA Quality System Regulations (820.30 design controls), European Regulatory Requirements (ISO 13485), and specifically IEC-62304. Lean Mindset and proven experience around Build, Measure, Learn (repeat) Demonstrates ability to problem solve Team oriented ability to motivate and work well with diverse, cross-functional teams Proven ability to influence and negotiate internally and with customers. Excellent oral and written communication skills Medical device product/industry/technical acumen Proven ability to work globally Strong analytical and process skills Strong project management skills Ability to work effectively within a matrix environment Ability to effectively handle conflict through proactive action, and direct and timely communication Experience in working with teams with a diverse cultural background Effective planning and organization skills, including the proven ability to work against multiple objectives

Job Description Summary This role will support the Production planning, output achievement work on the Ultrasound console and Probes refurbishment process. The Role will be overall responsible for Troubleshooting, repair and support daily output by following the Process Quality requirements for Ultrasound console Probes. Role will be responsible for Complying with the ISO 13485 Medical Device Regulation requirements always following GMP. Will Constantly provide productivity opportunities through Lean initiatives and will also ensure Quality EHS Compliance always. . Job Description Key responsibilities include: Comply with Repair Refurbishment requirement in Wipro GE Healthcare Repair Refurbishment facility to achieve the output on daily basis and support the business growth. Responsible for meeting the PSI targets by working on the unit on daily basis and meet the daily output target. Good Technical knowledge on the ultrasound console probes and capable of trouble shooting independently during repair refurb process. Work with team and initiate Lean ideas (Kaizens) to continually improve on the process productivity. Support team to Implement Good Manufacturing Practices, complying with all Quality regulations. Comply with ISO 13485, AERB, CDSCO and other Regulatory Requirements as needed Work with CFTs to achieve the desired output and meet the PSI numbers without miss. Adopt Lean and Advanced Manufacturing Practices for the day-to-day activities Co-ordinate with Global program team, Engineering, Process Engineer and QA to overcome the challenges during production. Support New Refurb products Program during Manufacturing validation activities Compliance to regulations. Ensure EHS, QMS Compliance in the Operations. Ability to work on transfer projects to train team members to attain refurbishment capability. Quality Specific Goals: Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, Central Repair Refurbishment Guidelines and applicable laws and regulations as they apply to this job type/positions Complete all planned Quality Compliance training within the defined deadlines Identify and report any quality or compliance concerns and take immediate corrective action as required. Proficient knowledge, understanding and leadership for International Trade Compliance, identify, report and resolve any trade compliance issues. Qualifications: Bachelors Degree Electrical Electronics, Medical Electronics, Bio Medical Engineering or equivalent. 2-5 Years of experience working in Repair Refurbishment activities Global Supply chain management. Knowledge on Lean principles Productivity mindset. Proven ability to meet deadlines in a fast-paced changing / challenging environment. Ability to work effectively in with cross-functional global stakeholders. Preferred Qualifications : Experience in Repair or Refurbishment or Supply Chain Proven ability to work on cross-functional, multi-cultural teams Creates energy to meet production targets and company goals through practical hands-on operational plans. Solid communication and analytical skills, including experience with communicating with others from different countries and cultures. Inclusion and Diversity We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership always with unyielding integrity. Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you d expect from an organization with global strength and scale, and you ll be surrounded by career opportunities in a culture that fosters care, collaboration and support. Disclaimer: GE HealthCare will never ask for payment to process documents, refer you to a third party to process applications or visas, or ask you to pay costs. Never send money to anyone suggesting they can provide employment with GE HealthCare. #LI-ML1 #LI-Onsite Relocation Assistance Provided: No

Demonstrate quality assertiveness and be able to represent quality function in various roles such as product support and lifecycle management. Assist in decision making for process improvement efforts and participate in continual process improvements. Experience in assessing and developing procedures to meet Digital Health regulatory requirements and guidance. Responsible for Quality Assurance of the Product Development and Lifecycle Management process. Provide quality role in assisting with generating design plans, reviewing design inputs, outputs, verification, validation and design transfer strategies for sustenance projects. Support risk management activities for NPD and sustaining engineering products, supporting post market activities such as complaint investigation, complaint trending, CAPA and FA processes. Supporting supplier quality management activities including collaborating with supplier management teams and conducting supplier audits. Support as a key quality representative in compliance audits and FDA/ministry of health (MOH) inquiries, FDA inspections and ISO/Notified body audits. Collaborate with teams to provide guidance for meeting Vantive Requirements and External Quality Standards as appropriate, including regulatory affairs to meet regulatory requirements. Experience in working with requirements for Test Method Validation, Calibration and Qualification of Test & Measurement equipment in labs used for Verification and Validation and Computer System Validations. BS engineering (Mechanical, Electrical and Electronics) and 6+ years in related Quality or Engineering field in the medical products industry. Strong interpersonal / communication / influencing / negotiation skills. Strong analytical and problem-solving skills. Working knowledge of FDA Regulations and Design Controls requirements for non-active devices and active devices. Experience in the application of design controls and compliance requirements in accordance with 21 CFR Part 820, ISO 13485, IEC 62304, ISO 14971, EU MDD / EU MDR, Agile SDLC.

Manage sales operations across a defined geographic area Set targets, monitor performance, and drive revenue Support team development and client relationships Analyze market trends and competitor activity