Quality Engineer

4 days ago

Coimbatore, Tamil Nadu, India NovintiX Full time

Experience Required:
4+ years

Industry:
Medical Devices

Location:
Coimbatore, India

Role Summary
This dual-role position combines Quality Engineering and Clinical Evaluation responsibilities to ensure that medical devices meet stringent global standards for safety, quality, and regulatory compliance. The ideal candidate will support quality systems, validation processes, risk management, supplier quality activities, and clinical evidence generation. They will also perform clinical literature reviews, analyze clinical data, and contribute to Clinical Evaluation Reports (CERs) aligned with international medical device regulations.

Key Responsibilities
Quality Engineering

  • Implement and maintain the Quality Management System (QMS) in compliance with ISO 13485, FDA QSR, and other applicable regulations.
  • Support product and process quality assurance, including design control, process validation (IQ/OQ/PQ), and production quality monitoring.
  • Conduct risk management activities (FMEA), CAPA investigations, root cause analysis, and corrective/preventive action implementation.
  • Collaborate with suppliers on qualification, quality control, audits, and corrective actions.
  • Manage and maintain quality documentation including SOPs, work instructions, protocols, and reports, following Good Documentation Practices (GDP).
  • Facilitate internal and external audits and assist during regulatory inspections.

Clinical Evaluation

  • Plan and execute clinical evaluation activities in accordance with MDR, IVDR, FDA, and other global regulatory requirements.
  • Collect, analyze, and assess clinical data including scientific literature, clinical studies, and PMCF (Post-Market Clinical Follow-up) data to support device safety and performance.
  • Prepare, update, and maintain Clinical Evaluation Reports (CERs) and related documentation.
  • Collaborate with Regulatory Affairs, R&D, and Quality teams to ensure clinical insights are incorporated into product development and risk management.
  • Support clinical vigilance activities by evaluating clinical data related to adverse events and field corrective actions.

Qualifications & Experience

  • Bachelor's degree in Engineering, Life Sciences, Biomedical Sciences, or a related field; advanced degrees preferred.
  • Minimum of 4+ years of experience in quality engineering with exposure to clinical evaluation in the medical device industry.
  • Strong understanding of regulatory standards such as ISO 13485, EU MDR, FDA QSR, and ISO 14971.
  • Experience with QMS implementation, process validation, design control, and risk management.
  • Familiarity with clinical evaluation requirements, scientific literature review methodologies, and CER development.
  • Experience in post-market surveillance and clinical vigilance is an added advantage.
  • Strong analytical, problem-solving, and communication skills with the ability to work collaboratively across departments.

Key Competencies

  • Strong knowledge of quality systems and regulatory compliance
  • Expertise in clinical data evaluation and literature assessment
  • Proficiency in risk management and CAPA processes
  • Ability to prepare and maintain Clinical Evaluation Reports (CERs)
  • Audit readiness and inspection support
  • Cross-functional collaboration and stakeholder management

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