Quality Engineering Manager

What you'll do

• Lead quality engineering team to ensure products meet regulatory standards and company expectations.
• Oversee development, implementation, and maintenance of quality systems in compliance with GMP, QSR, ISO 13485, EU MDR, and SOTA.
• Investigate and resolve product quality issues, non-conformances, and CAPA across engineering and manufacturing operations.
• Coach team on Process Improvement tools like DMAIC, RCA, 5 Whys, Fishbone analysis, and cause mapping.
• Manage verification and validation protocols including IQ, OQ, and PQ for medical device components.
• Mentor and coach candidates pursuing FTQ Level 1 certification and provide strategic guidance for higher certifications.

What we're looking for

• Bachelor’s degree in Biomedical, Mechanical, or Industrial Engineering with 5 years of medical device industry experience as a Quality Engineer.
• Master’s degree in relevant engineering field with 3 years of medical device industry experience as a Quality Engineer.
• At least 3 years’ experience with GMP, 21 CFR Part 820 QSR, ISO 13485, EU MDR, and SOTA standards.
• Expertise in risk assessments, PHA, PFMEA, non-conformances, CAPA, DMAIC, RCA, DOE, statistical analysis tools, and V&V protocols.
• Proficiency with Minitab and Power BI for data-driven decision-making and quality system management.
• Extensive knowledge of product lifecycle management, including authoring technical documentation and FTQ principles.