Quality Engineer & Clinical Evaluation Specialist

Experience Required:

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Role Summary

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