Quality Engineer II

Katalyst CRO; Dexter (MI); On-site; USD 75,000 - 90,000; Full time

Job summary

Katalyst CRO in Dexter, Michigan, is seeking a Quality Engineer II with experience in medical device manufacturing and quality assurance. Candidates should have a Bachelor's degree in engineering and at least 4 years of relevant experience. Key responsibilities include supporting process validation, performing equipment qualification, and maintaining compliance documentation. The ideal candidate will be familiar with FDA regulations and quality systems, utilizing tools like Minitab for statistical analysis. Competitive salary and benefits offered.

Qualifications

• Minimum 4+ years of experience in medical device manufacturing or quality engineering.
• Hands-on experience with IQ/OQ/PQ validation and process validation.
• Strong knowledge of FDA and ISO standards.

Responsibilities

• Support and execute process validation lifecycle activities.
• Develop, review, and execute validation protocols and documentation.
• Maintain audit-ready documentation for compliance.

Skills

Process validation

FDA compliance

Risk management

Statistical analysis

SOP development

Education

Bachelor's degree in engineering

Tools

Minitab

Microsoft Office

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.

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.