Compare your current skills to what this opportunity needs—we'll show you what you already have and what could strengthen your application.
Job Description
Quality Engineer II Katalyst Healthcares & Life Sciences - 4.0 Dexter, MI Job Details Contract 3 hours ago Qualifications ISO standards Regulatory compliance Bachelor's degree in engineering
FMEA FDA
regulations Engineering validation
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.
