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Product Complaints Quality Engineer
Quality Engineer
Senior Quality Engineer to investigate product complaints, lead CAPA processes, and ensure regulatory compliance for medical devices.
About the role
Key Responsibilities
- Investigate and resolve product complaints and non-conformances in medical devices
- Lead root cause analysis (RCA) and implement corrective and preventive actions (CAPA)
- Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and other regulatory requirements
- Collaborate with manufacturing, R&D, and regulatory teams to address quality issues
- Develop and maintain quality documentation, including risk management files
- Conduct audits and inspections to verify adherence to quality standards
Requirements
- Bachelor's degree in Engineering, Quality Assurance, or related field
- 5+ years of experience in quality engineering, preferably in medical devices
- Strong knowledge of quality management systems (QMS) and regulatory frameworks
- Experience with CAPA processes, risk management, and Six Sigma methodologies
- Excellent problem-solving and communication skills
Skills
quality systemsroot cause analysiscaparegulatory compliancemedical device standardssix sigma