309 Iso 13485 Jobs - Page 12

What you will do: Complaint handling and Product investigations of medical devices Perform Visual, functional, dimensional, functional inspection & RCA of field returned products. Maintain and ensure complaint files are complete and accurately reflect corresponding complaint activities. Risk management -Risk assessment Review of Process flow, DHR, Inspection plans, Measurement techniques, GRR s etc. Review and analyze Literatures such as Clinical reports, PMCF reports, National register etc. to identify Complaints Create PMS plan, PMS report, PSUR report as per EUMDR, Trend report & Complaint analysis. Other tasks as assigned by manager. What you need: Required skills: B. Tech / M.Tech Mecha...

What you will do Complaint handling and Product investigations of medical devices Perform Visual, functional, dimensional, functional inspection & RCA of field returned products. Maintain and ensure complaint files are complete and accurately reflect corresponding complaint activities. Risk management -Risk assessment Review of Process flow, DHR, Inspection plans, Measurement techniques, GRR s etc. Review and analyze Literatures such as Clinical reports, PMCF reports, National register etc. to identify Complaints Create PMS plan, PMS report, PSUR report as per EUMDR, Trend report & Complaint analysis. Other tasks as assigned by manager. What you need: Required skills: B. Tech / M.Tech Mechan...

HCLTECH is conducting a Direct Walk-in Drive in the Medical Devices sector, hashtag#HCLTECH hashtag#Megadrive hashtag#Hyderabad hashtag#on #25th hashtag#May #2025 for hashtag#PMSAnalyst hashtag#ComplaintHandling hashtag#MedicalDomain hashtag#BtechMechanical HCLTech is seeking candidates for the role of Compliance Engineer in the Medical Devices sector in Hyderabad. COntact Person --Divya /Joy /Jenifer **Address:** Sy.No .30,34,35 & 38, Avinash Hitech City2 Society Gachibowli Village, Serillimgampally Mandal, H-01B, Cafeteria, Phoenix Avance Sez Internal Rd, Siddiq Nagar, HITEC City, Hyderabad, Telangana 500081, India. **Job Details:** - **Position:** PMS Service Medical Devices Complaints Ha...

HCLTECH is conducting a Direct Walk-in Drive in the Medical Devices sector, hashtag#HCLTECH hashtag#Megadrive hashtag#Hyderabad hashtag#on #25th hashtag#May #2025 for hashtag#PMSAnalyst hashtag#ComplaintHandling hashtag#MedicalDomain hashtag#BtechMechanical HCLTech is seeking candidates for the role of Compliance Engineer in the Medical Devices sector in Hyderabad. **Address:** Sy.No .30,34,35 & 38, Avinash Hitech City2 Society Gachibowli Village, Serillimgampally Mandal, H-01B, Cafeteria, Phoenix Avance Sez Internal Rd, Siddiq Nagar, HITEC City, Hyderabad, Telangana 500081, India. **Job Details:** - **Position:** PMS Service Medical Devices Complaints Handling - **Experience:** 0 to 1 years...

Regulatory Strategy & Compliance – US FDA, EU MDR, CDSCO Documentation & Regulatory Submissions Regulatory Monitoring & Reporting UDI Submission – GUDID / EUDAMED Regulatory Audits, Inspections, CAPAs & NCs Closure Required Candidate profile BE/BTech in Mechanical, Biomedical, Biotech, or related fields Min 2 years of exp. in RA for medical devices Knowledge of U.S. FDA, EU MDR, CDSCO regulations RAC/GATE certification is a plus

Job Summary We are looking for a detail-oriented and experienced Quality Control Engineer to join our manufacturing team. The ideal candidate will be responsible for implementing and overseeing quality control processes, ensuring all products meet national and international medical device standards, and working closely with production and R&D to resolve quality issues. Key Responsibilities Conduct in-process and final quality inspections for medical devices in accordance with GMP and ISO 13485 standards. Develop and maintain QC protocols, SOPs, and inspection reports. Ensure compliance with regulatory requirements such as CDSCO, MDR 2017, ISO 13485, and CE. Perform root cause analysis and co...

1. Experience in manufacturing operations 2. 6+ years experience in a supervisory capacity and leadership roles 3. Bachelors degree in production management, Engineering, or a related field. 4. Excellent project management skills 5. Experience in creating procedures and monitoring product servicing activities 6. Experience in production and quality control as per ISO 13485 7. Decent understanding of medical device manufacturing processes 8. Proven track record of successfully training employees in productivity and safety 9. Ability to coach and mentor employees on a one-on-one basis as well as a group 10. Knowledge of project management principles and practices 11. Knowledge of business and ...

We are seeking a skilled Software Test Engineer with experience in the medical device industry to join our dynamic team. The candidate will collaborate closely with cross-functional teams, including clinical, product, software, firmware, and hardware teams, to ensure product quality and compliance with industry standards. This role involves defining test strategies, creating test plans, executing test cases, and implementing automation solutions. Requirements and Qualifications: Bachelor's degree in Computer Science or related field 4 years of hands-on experience in software testing 2 years of experience in the regulated medical device industry Hands-on experience with cloud-based SaaS appli...

We are seeking a skilled Software Test Engineer with experience in the medical device industry to join our dynamic team. The candidate will collaborate closely with cross-functional teams, including clinical, product, software, firmware, and hardware teams, to ensure product quality and compliance with industry standards. This role involves defining test strategies, creating test plans, executing test cases, and implementing automation solutions. Requirements and Qualifications: Bachelor's degree in Computer Science or related field 4 years of hands-on experience in software testing 2 years of experience in the regulated medical device industry Hands-on experience with cloud-based SaaS appli...

Role & responsibilities Job Summary : We are seeking an experienced and highly motivated IVDR Technical Manager to join our team. In this role, you will lead and facilitate necessary initiatives in order to ensure DNV complies with all regulatory and accreditation requirements relevant for in-vitro devices services and meet expectations on knowledge and competence from authorities, market units, customers and other partners. The ideal candidate will have a strong background in regulatory affairs, technical documentation, and quality management systems, with the ability to manage the technical aspects of IVDR compliance for a diverse portfolio of IVD products. Key Responsibilities : Competenc...

We are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team and play a key role in ensuring the regulatory compliance of our engineering services projects for leading global Healthcare/ MedTech clients. You will work closely with our engineering and quality teams, as well as clients regulatory team, to navigate the regulatory landscape and ensure a smooth and successful product launch. Roles & Responsibilities : Collaborate with clients regulatory team to understand their specific regulatory requirements and strategies for its MedTech products. Provide regulatory guidance and support to our engineering and testing teams, ensuring that the system design, d...

Candidates experience with ISO 15378/GMP, ISO 13485, and IQ, OQ, and PQ, particularly in relation to the pharmaceutical industry. Position :- Quality Assurance- Engineer- No of positions:- 1 Location:- Isnapur- Hyderabad Preferred candidate profile

Executive (RA, QA) ( Level I/ II) Executive (RA, QA) ( Level I/ II) subrat kumar 2025-04-24T12:40:11+05:30 Executive (RA, QA) ( Level I/ II) JC OrthoHeal Private Limited is looking for Executive (RA, QA) ( Level I/ II) to grow our footprints. JOB ID: OHRA250401 Job family Regulatory Affairs Position Title E xecutive (RA, QA) ( Level I/ II) Job Type Full Time Manjuser, Vadodara Nature of Work On-site Company Name JC OrthoHeal Private Limited Updated on 24.04.2025 OrthoHeal is a leading Med-Tech company specializing in orthopedic medical devices. The company focuses on improving post-operative orthopedic recoveries and innovating technologies to enhance patient care. OrthoHeal s flagship produ...

Role & responsibilities BE/BTech/ME/M-Tech in Electrical & Electronics Engineering, with 7 to 9 years of experience New Product Introduction (NPI) and Product Life Cycle Management Candidate having expertise in Electrical/Electronics HW Circuit Design and development Candidate having expertise in Altium or CADENCE or Mentor Graphics Product Obsolescence Management/Sustenance and Value Engineering Understanding & on the job application of standards like ISO 14971, ISO 13485, IEC 60601-1 Understanding & exposure to regulatory aspects pertaining to FDA, MDR, NMPA, TGA, HC, MHLW Understanding & Exposure to D/P-FMEA, Design for Usability, Design for Manufacturing/Assembly, Design for Reliability ...

Job Position: PMS Service Medical Devices Complaints Handling Job Description: To handle medical device customer allegations in complaints management system . Candidate with knowledge on Medical devices usage, Complaint Evaluation, Investigation, Medical devices reporting including post-market surveillance (PMS) and CAPA. Roles and Responsibilities: To work on Complaint handling Process Evaluation, Regulatory Assessment, Investigation Work with lead in completing daily assignation. Organize and manage daily work allocation Complaints remediation using work instruction, compliance to process To drive efficiency and compliance. Collaborate with of cross function team (CFT) such as Intake, MDR,...

Develop, implement, and maintain the QMS in alignment with ISO 13485:2016 standards. Create, review, and update QMS documentation, including quality policies, procedures, and work instructions. Support during External (Notified Body for ISO 13485:2016) and Corporate Audits and Provide real-time support to the auditors by delivering requested documents, records, and evidence. Maintain and update the Document Control System (Windchill) for controlled documents, including SOPs, work instructions, forms, and records. Ensure document revisions, approvals, and distribution align with company policies and regulatory requirements (ISO 13485, FDA, EUMDR, etc.). Coordinate with cross-functional teams ...

Medical Writer / Technical Content Writer - Internship This internship is ideal for someone passionate about simplifying complex medical or technical information into clear, structured documents and engaging content. Required Skills: Draft and organise documents such as user manuals, work instructions, clinical evaluations, and regulatory submissions. Format documents according to internal templates and regulatory guidelines (e.g., ISO 13485, MDR, FDA, IVDR). Research and write blogs, articles, white papers, and social media content focused on regulatory trends, product safety, and medtech innovation. Contribute to internal knowledge bases and client training materials. Work with subject mat...

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 susta...

Conduct regular inspections at all stages, including Incoming, In-Process, and Final Inspection. Identify non-compliance issues and opportunities for improvement. Ensure timely issuance of product identification and status labels. Enforce environment, health, and safety practices, including waste management and accident prevention. Support inspection activities for new product development as assigned. Complete documentation in compliance with ISO 9001:2015 and ISO 13485:2016. Monitor temperature, humidity, and cleanroom/workplace conditions. Collaborate with cross-functional teams to integrate quality control measures. Collect and analyze inspection data to drive corrective and preventive ac...

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...

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 an...

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 ...

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 w...

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, enjo...

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. Es...