Sr. Quality Engineer

Job Summary:

• We are seeking an experienced Senior Quality Engineer with expertise in Medical Device Quality Engineering and Regulatory Compliance. The ideal candidate will have hands-on experience in medical device quality systems, risk management, complaint handling, post-market surveillance, CAPA, and regulatory compliance.
• This role supports product development, manufacturing, validation, and quality assurance activities while ensuring compliance with FDA regulations, ISO standards, and global medical device requirements.

Roles & Responsibilities:

• Lead design transfer and production support activities while ensuring compliance with FDA regulations and ISO 13485 requirements.
• Support manufacturing readiness and quality initiatives throughout product development programs.
• Manage quality activities for assigned product components and subassemblies to ensure design integrity and manufacturability.
• Investigate non-conformances using root cause analysis and drive CAPA implementation within the Quality Management System (QMS).
• Develop, maintain, and update Design, Process, Application, and System FMEAs while supporting risk mitigation activities.
• Support qualification and validation activities, including IQ, OQ, and PQ.
• Identify, evaluate, and implement compliant solutions for engineering and manufacturing challenges.
• Maintain and continuously improve Quality Management System (QMS) processes.
• Collaborate with Engineering, Manufacturing, Operations, and Quality teams to resolve product and process issues.
• Interpret and apply FDA regulations, ISO standards, and medical device quality requirements throughout the product lifecycle.
• Support internal, external, customer, and regulatory audits and ensure timely closure of audit findings.
• Utilize statistical tools and data analysis techniques to improve product quality, reliability, and manufacturing processes.
• Ensure compliance with medical device quality standards and regulatory requirements across all quality engineering activities.

Requirements:

• Bachelor's degree in mechanical engineering or a related engineering discipline.
• ASQ Certified Quality Engineer (CQE) certification is preferred.
• Minimum 6 years of experience in the Medical Device industry.
• Experience working in highly regulated manufacturing environments.
• Experience supporting product development, manufacturing, and quality engineering activities.
• Experience managing complaint handling and Post Market Surveillance (PMS) activities.
• Experience managing Non-Conformance (NC), CAPA, and quality investigations.
• Experience supporting internal, external, and regulatory audits.

Technical Skills:

• Strong knowledge of Medical Device Quality Systems.
• Hands-on experience with ISO 13485:2016/2019.
• Strong knowledge of FDA 21 CFR Part 820.
• Knowledge of Medical Device Regulations (MDD/MDR).
• Experience with Medical Device Risk Management (ISO 14971).
• Experience with Design, Process, Application, and System FMEA.
• Experience with Quality Management Systems (QMS).
• Experience supporting IQ, OQ, and PQ qualification activities.
• Proficiency in Design of Experiments (DOE).
• Experience performing descriptive and non-parametric statistical analysis.
• Experience with reliability analysis and statistical data interpretation.
• Strong knowledge of Regulatory Compliance and Medical Device Quality practices.