About this role

Ensure compliance with ISO 13485, FDA 21 CFR 820, EU MDR, and other applicable regulatory and customer requirements.
Provide quality engineering support for manufacturing processes, including molding, assembly, inspection, and packaging.
Oversight process validations (IQ, OQ, PQ) and maintain validation documentation.
Participate in PFMEA, Control Plans, and risk management activities.
Oversight and support root cause investigations using tools such as 8D, Fishbone, and 5-Why.
Support quality planning and risk assessments for new products and transfers.

Bachelor’s degree in Engineering, Quality, Science, or a related discipline.
2–5+ years of quality engineering experience in a regulated manufacturing environment, preferably medical device, pharmaceutical, or healthcare packaging.
Experience with molding or precision manufacturing processes preferred.
Strong knowledge of ISO 13485, FDA 21 CFR 820, Risk management (ISO 14971), Process validation.
Experience with statistical tools and SPC.
Proficiency in MS Office; experience with eQMS systems is a plus.

Quality Assurance Engineer

Key skills