Senior Engineer, Quality

How you'll make an impact:

• Investigate complex manufacturing product quality and compliance issues reported internally and/or from the field, analyze results, determine root causes, and initiate and review reports (e.g., Non-Conformances, CAPA, Audit resolutions).
• Exercise independent judgment in owning complex quality investigations, leading cross-functional teams to align on root cause, risk impact, containment, and corrective actions, and driving systemic actions that prevent recurrence.
• Develop, update, and maintain the technical content of risk management files and procedures.
• Lead technical studies and author technical reports. Apply statistical techniques to determine appropriate sample sizes and confidence levels.
• Optimize complex manufacturing processes using quality engineering methods (e.g., Six Sigma and Lean) to drive design for manufacturing and continuous process improvement.
• Train, coach, and guide peers and junior employees.

What you'll need (Required):

• Bachelor's degree in Engineering or Scientific field with a minimum of 4 years relevant experience in Quality Engineering, Product & Process Engineering, Quality Systems, or Manufacturing; OR
• Master's degree in Engineering or Scientific field with 3 years of experience.

What else we look for (Preferred):

• GDP and GMP proficiency and experience working in medical device, pharma, or biotech industry.
• Strong problem-solving, organizational, analytical, strict attention to detail, and critical-thinking skills.
• Solid leadership skills and the ability to influence change.
• Understanding of manufacturing, quality, and risk management standards.
• FDA Quality System Regulation / 21 CFR Part 820, ISO 13485, ISO 14971, and EU MDR awareness.
• Experience working with inspection and measurement tools & equipment (e.g. microscope, TAPPI, burst tester, tensile tester).
• Nonconformance and CAPA management experience utilizing investigation tools for root cause analysis (e.g. Five Whys Analysis, Fishbone diagram, Flow Chart/Process Mapping).
• Working knowledge of statistical data analysis and SPC (Minitab proficiency).
• Process / Equipment qualification & validation experience (Test method validation, IQ/OQ/PQ, Tool and fixture IQ).
• Expertise in usage of MS Office Suite and experience using digital productivity tools and AI-enabled applications.