7 Iso 14971 Jobs

Role & responsibilities: Process Development &Optimization Define, document, and improve engineering workflows, protocols, and D&D procedures. Collaborate with cross-functional teams (Design, QA/RA, Manufacturing, Supply Chain) to standardize and streamline development processes. Support Design Control processes including Design Inputs/Outputs, Verification, and Validation activities. Technical Documentation Management Create, maintain, and control engineering documentation such as: Design History Files (DHF) Device Master Records (DMR) Engineering Change Orders (ECO) Risk Management Files (ISO 14971) Ensure traceability and version control using QMS tools. Assist in the preparation and formatting of documents for regulatory submissions (FDA, EU MDR). Compliance & Quality Support Ensure documentation and processes meet applicable standards: ISO 13485, 21 CFR Part 820, IEC 60601, and other regulatory requirements. Support internal and external audits by providing required documentation and process maps. Knowledge Transfer & Team Support Maintain structured repositories of technical documentation and templates. Train engineers and D&D staff on documentation best practices, process adherence, and use of documentation tools. Tools & Systems Use and help maintain Product Lifecycle Management and Quality Management Systems (QMS). Work with tools such as SolidWorks PDM, Windchill, Arena, or equivalent for document and change control. Preferred candidate profile

Job Title Design Quality Engineer Job Description Job title: Design Quality Engineer - Medical Devices The Design Quality Engineer DQE provides independent oversight of the design input process, design V&V activities, design transfer and product realization, and performance in the field to ensure that all design requirements are effectively met. The DQE also provides analytics to the Business on the efficacy and efficiency of the design and product realization processes Your role: Ensure appropriate quality plans are made that include all stages of the life cycle of the product and supports Quality Plan design. Validate key design inputs like usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability, and costs. Provide effective oversight of the execution of the Quality Plan, any Risk Management activities, and of all design related activities during the product/system lifecycle. Perform independent technical assessment on product quality performance and post market product quality analysis. Can Lead quality related problem solving and root cause analysis during design and manufacturing. Uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiates field actions when required. Performs independent technical assessment on product quality performance and post market product quality analysis. Provide leadership and oversight to ensure Quality Management System Compliance. Be able to plan, control, and assure product and process quality in accordance with quality principles, which include planning processes, material control, acceptance sampling, and measurement systems. Ensure the compliance requirements are met during Design review , design verification & Design validation , Design transfer. Apply and facilitate Design for Quality & Reliability best practices (FMEAs, robust design, V&V, root cause analysis & problem solving). You're the right fit if: (4 x bullets max) An Engineering degree in any discipline with at least 8+ years of relevant industry experience. . Core expertise in Design Quality, Systems Engineering, or Reliability Engineering. Medical device industry experience is mandatory . Ability to define detailed systems quality and reliability plans for new medical product developments to ensure those are safe, effective and reliable. Ability to contribute to Risk Management and lead FMEA activities for new products and assurance that control measures are translated in appropriate critical requirements. Strong exposure to application of Design Controls ability to do thorough Design Reviews during new product development to ensure robust designs that further improve patient safety and product quality. Ability to partner with V&V teams to assure thorough Verification, Validation and Usability testing. Ability to lead reliability analysis to assess the risks associated with design concepts. Experience with adequate and accurate review of DHF and DMR documents. Understanding of global medical device regulations, requirements, and standards, such as 21CFR820, ISO13485, EU MDR, , and ISO 14971. Experience with working in multidisciplinary teams in a high-tech R&D environment. You continuously strive for excellence as a way of life and can inspire others to adopt this mentality of prioritizing quality above all else. You are a self-starter who embraces the change 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. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. . Learn more about . . Discover . . Learn more about . If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion .

Designation: Staff Specialist Labeling & Technical Publications Experience: 7–11 years Location: Gurgaon (GGN) or Bangalore (BLR) Interview Rounds: 8 Work Mode: Hybrid / Onsite Role Overview We are seeking a highly skilled professional to manage and coordinate global labeling and technical publications for medical device products. This role involves regulatory documentation, translation workflows, quality compliance, and cross-functional project leadership within a regulated environment. Key Responsibilities Manage and approve labeling jobs using tools like Microsoft Teams Planner and PLM systems. Coordinate document translations with external vendors and ensure regulatory compliance. Publish approved documents to global portals and maintain accurate versions. Lead and support Engineering Change Requests (ECR/ECN) related to labeling and documentation. Act as the local labeling lead for global projects, tracking progress, managing stakeholders, and reporting risks. Ensure compliance with global quality and regulatory standards (EU MDR, ISO 14971, IEC 62366). Support risk management processes and integrate risk measures into product labeling. Review quality assurance documentation related to product sustenance and lifecycle management. Manage label printing for regulatory submissions and large-scale updates. Must-Have Skills & Qualifications 7–11 years of work experience, with 5+ years in technical writing, labeling, or quality assurance in the medical device domain. Hands-on experience with documentation systems such as onePLM, SharePoint, or similar. Solid understanding of regulatory frameworks including EU MDR, ISO 14971, and IEC 62366. Strong project management capabilities with the ability to manage multiple projects and timelines. Bachelor’s degree in Engineering, Science, or a related technical field. Excellent communication and stakeholder management skills.

1. Regulatory Knowledge: Understanding of EU MDR 2017/745: In-depth knowledge of the MDR and its application to medical devices and accessories, including Annexes and specific requirements related to accessories. Accessory Classification: Familiarity with how accessories are classified under the MDR (whether they are classified as a medical device or fall under other regulatory frameworks). Knowledge of Harmonized Standards: Knowledge of relevant European harmonized standards and guidelines that apply to medical devices and accessories (e.g., ISO 13485, ISO 14971). 2. Quality Management System (QMS) Expertise: ISO 13485 Compliance: Strong understanding of ISO 13485 requirements and its application to both medical devices and accessories, ensuring quality management systems are in place. Document Control & Change Management: Experience managing the documentation process, ensuring proper records, specifications, and design files for both the medical device and its accessories. Risk Management: Knowledge of ISO 14971 for risk management, specifically in the context of accessories and their role in the overall safety of the medical device. 3. Product Lifecycle Management: Design and Development: Ability to oversee the quality aspects of product design and development for accessories, ensuring compliance with regulatory requirements from concept to delivery. Post-Market Surveillance & Vigilance: Experience in setting up post-market surveillance systems for accessories, including reporting adverse events and ensuring continued compliance after the product is on the market. Clinical Evaluation: Understanding of clinical evaluation requirements for both medical devices and accessories, ensuring safety and performance criteria are met. 4. Supplier and Vendor Management: Supplier Qualification and Audits: Skills in qualifying suppliers for the accessories, ensuring they meet the necessary regulatory and quality standards. Supplier Quality Assurance: Managing quality expectations for external suppliers, especially if accessories are sourced from third-party vendors. 5. Cross-functional Collaboration: Collaboration with R&D and Design Teams: Ability to work closely with design and engineering teams to ensure quality is incorporated into the accessory's design from the start. Regulatory Affairs Coordination: Work with the regulatory affairs team to ensure accessories are compliant with applicable regulations before market release. Customer and Stakeholder Communication: Effective communication with internal stakeholders and customers about the accessorys quality and regulatory status. 6. Training and Leadership: Team Leadership and Training: Ability to lead and train teams on the quality standards required for accessories, promoting a culture of quality. Internal Audits and Compliance Checks: Expertise in conducting internal audits to assess compliance with MDR and ISO standards for accessories, identifying areas for improvement. 7. Problem-Solving and Continuous Improvement: Root Cause Analysis: Expertise in identifying and analyzing quality issues related to accessories, utilizing tools such as CAPA (Corrective and Preventive Actions) and root cause analysis. Continuous Improvement: Driving a culture of continuous improvement, including the application of Lean, Six Sigma, or similar methodologies to optimize processes related to accessories. 8. Knowledge of EU Market Authorization: CE Marking for Accessories: Familiarity with the requirements and process for obtaining CE marking for accessories, including the necessary technical documentation, risk assessment, and clinical evaluations. Conformity Assessment Procedures: Knowledge of the conformity assessment process under the MDR for both the medical device and its accessories, including involvement of Notified Bodies if applicable. bodies, especially for post-market surveillance, vigilance, and compliance audits. 9. Language and Communication Skills: Multilingual Communication: If dealing with international suppliers or regulatory bodies, proficiency in relevant languages (e.g., English, German) would be beneficial for effective communication and documentation. Technical Writing Skills: Ability to create clear and concise technical documentation, including quality plans, reports, and regulatory submissions for accessories. 11. Software and Tools: QMS Software: Proficiency in using quality management software systems to track documentation, CAPAs, audits, and regulatory compliance. Risk Management Tools: Familiarity with risk management software tools to assess, mitigate, and document risks associated with accessories.

Mandatory Skills :- Risk Management. ISO 14971, FDA CFR 820, ISO 13485, Risk Mitigation, Medical Devices. Location : Bangalore Notice period : Immediate to 45 days. Skill Sets: 1. 7-12 years working experience in a regulated industry specially as a medical device of relevant experience in medical device risk management. 2. Knowledge in ISO 13485, ISO 14971, FDA CFR 820 3. Medical Device Risk analysis, risk evaluation, risk control, Risk mitigation implementation 4. Good written and verbal communication in English language 5. Strong interpersonal skills 6. Knowledge and understanding of international safety standards for medical devices 7. Related experience with Medical Device Risk analysis and Cybersecurity Risk management Responsibilities: 1. Leads Risk Management efforts, processes and process improvements for assigned product/business portfolio. 2. Knowledge of remediation of risk files as per ISO 14971:2019. 3. Develops and maintains Risk Management Files that include risk management plans, hazard analyses, risk assessments and risk management matrix. 4. Lead issue impacts assessments to calculate risks associated with defects and complaint records. 5. Collaborates as risk management subject matter expert with development teams to ensure the comprehensive implementation of risk control measures are compliant to local requirements as and international standard ISO 14971 6. Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross-function teams. Additional Advantage: Good knowledge of SDLC (IEC-62304) and SaMD .

Role & responsibilities 'Total 4-7 years of hands on system engineering experience involving electrical, mechanical, firmware out of which at least 3 years for medical devices is compulsory Proficient in product architecture design, define system interface & system verification strategy Proficient in products requirements capturing/ understanding. Proficient in product compliance testing involving mechanical, safety, EMC & environmental tests Good understanding of product reliability and functional safety Familiarity with the Design Controls in Medical Devices Experience in performing Risk Assessment & Control of the Electro-Mechanical Devices Experience in DFMEA, PFMEA, UFMEA and Software Risk Assessment Ability to review/ guide team on verification protocol for electro-mechanical medical device and define acceptance criteria Experience in prototype Manufacturing (Vendor Co-ordination, manufacturing, etc.) Understanding of handling of complete product traceability Experience working with standards such as ISO 13485, ISO 14971, IEC 60601, ISO 10993

Seeking Sr. RA Specialist for Product Environmental Compliance. Expertise in medical device regulations, BOMCheck, environmental reporting, and compliance. 5+ years experience in regulatory or product environmental compliance within medical devices