Sr. Quality Engineer

We are seeking an experienced Sr. Quality Engineer with strong expertise in Medical Device Quality and Regulatory Compliance. The ideal candidate will have hands-on experience in quality systems, risk management, complaint handling, post-market surveillance, and regulatory compliance within the medical device industry.

• Bachelor's degree in mechanical engineering or a related field.
• ASQ CQE certification is preferred.
• Minimum 6 years of experience in the Medical Device industry.
• Strong understanding of Medical Device Quality Systems and regulatory requirements.
• Hands-on experience with ISO 13485:2016/2019 and 21 CFR Part 820.
• Experience in Complaint Handling and Post Market Surveillance (PMS) activities.
• Knowledge of global Medical Device Regulations including MDD/MDR.
• Experience managing Non-Conformance (NC) processes, CAPA, and internal/external audits.
• Strong background in Medical Device Risk Management (ISO 14971).
• Experience with Application, Process, Design, and System FMEA methodologies.
• Proficiency in statistical tools and techniques, including Design of Experiments (DOE).
• Ability to perform descriptive and non-parametric statistical analyses.
• Experience using advanced statistical methods for reliability analysis and data-driven decision making
• Lead design transfer and production support activities while ensuring compliance with FDA and ISO 13485 requirements.
• Support manufacturing readiness and quality initiatives across product development programs.
• Manage quality activities for assigned product components/subassemblies to ensure design integrity and manufacturability.
• Investigate non-conformances using root cause analysis and drive CAPA activities within the Quality Management System.
• Develop and maintain FMEAs, support risk mitigation efforts, and lead issue resolution activities.
• Support qualification activities including IQ/OQ/PQ.
• Identify and implement compliant solutions for engineering and production challenges.
• Maintain and improve Quality Management System (QMS) processes.
• Collaborate with cross-functional teams including Engineering, Manufacturing, Operations, and Quality.
• Interpret and apply medical device regulations and quality standards throughout the product lifecycle.
• Support internal, external, and regulatory audits and ensure timely closure of audit findings.