Bachelor's degree in engineering (Quality, Mechanical, Biomedical, Industrial, or related field)
4+ years of relevant experience in medical device manufacturing or quality engineering
Hands-on experience with IQ/OQ/PQ validation and process validation
Strong knowledge of FDA, EU MDR, and ISO standards for medical devices
Familiarity with Minitab for statistical analysis and process improvements
Responsibilities
Support and execute process validation lifecycle activities including IQ, OQ, and PQ validations
Develop, review, and execute validation protocols, SOPs, and test method validation documentation
Perform equipment qualification activities and maintain compliance documentation
Create and maintain PFMEAs, Control Plans, and risk management documentation
Conduct FAIs and dimensional verification supporting manufacturing changes
Support computer system/software validation and change control activities for medical devices
Utilize DOE methodologies and statistical analysis for process improvements
Collaborate with cross-functional teams ensuring compliance with medical device regulations
Benefits
Opportunity to work in a regulated medical device environment
Enhance skills in quality engineering and regulatory compliance
Involvement in cross-functional collaboration among quality, manufacturing, and engineering
Contribution to continuous improvement initiatives
Engagement with cutting-edge medical device validation processes
Full Job Description
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.
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 & 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 & 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.
