Quality Engineer II

Quality Engineer II

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.

Experienced in supporting process validation lifecycle activities, test method validations, dimensional verification, FAIs, and manufacturing process improvements while ensuring compliance with ISO 13485, ISO 14971, IEC 60601, and FDA 21 CFR Part 820 requirements.

Roles and Responsibilities

• 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.

Education and Experience

• 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.