Quality Engineer II

Job Summary

Quality Engineer II with experience in medical device manufacturing, process validation, and quality systems compliance within FDA-regulated and EU MDR environments. Skilled in IQ/OQ/PQ validation, process characterization, PFMEA, control plans, risk management, SOP development, and change control activities.

• Support and execute process validation lifecycle activities including Process Characterization, IQ, OQ, and PQ validations.
• Develop, review, and execute validation protocols, reports, SOPs, and test method validation documentation.
• Perform equipment qualification activities and maintain validation compliance documentation.
• Create and maintain PFMEAs, Control Plans, and risk management documentation aligned with medical device quality systems.
• Conduct FAIs, dimensional verification, and support manufacturing and packaging change evaluations.
• Support computer system/software validation (CSV) and change control activities for medical devices.
• Utilize DOE methodologies and Minitab for statistical analysis and process improvements.
• Collaborate with Quality, Manufacturing, Engineering, and Regulatory teams to ensure compliance with FDA 21 CFR Part 820, EU MDR 2017/745, ISO 13485, ISO 14971, and IEC 60601 standards.
• Maintain audit-ready documentation and support continuous improvement initiatives within regulated manufacturing environments.

• Bachelor's degree in engineering (Quality, Mechanical, Biomedical, Industrial, or related field).
• Minimum 4+ years of relevant experience in medical device manufacturing or quality engineering environment.
• Hands‑on experience with IQ/OQ/PQ validation, process validation, DOE, PFMEA, risk management, and test method validation.
• Strong knowledge of FDA 21 CFR Part 820, EU MDR 2017/745, ISO 13485, ISO 14971, and IEC 60601 standards.
• Experience with Microsoft Office applications, Minitab, and validation documentation systems preferred.