Med Device Quality Investigation Engineer

Katalyst CRO; Dexter (MI); On-site; USD 85,000 - 110,000; Full time

Job summary

Katalyst CRO in Michigan is seeking a Quality Complaint Investigation professional to support complaint investigations, CAPA activities, and continuous improvement in a regulated medical device environment. The role involves analyzing quality data, performing root cause analyses, reviewing GMP documentation, and ensuring compliance with FDA QSR 21 CFR 820.

You will collaborate cross-functionally, prepare investigation summaries, and drive corrective actions to improve product quality and

Qualifications

• Bachelor's degree in engineering (B.E./B.Tech or equivalent).
• Experience in the Medical Device industry and FDA QSR knowledge preferred.
• Familiarity with CAPA processes and quality systems.
• Experience in complaint handling, investigations, and root cause analysis.
• Proficient in MS Office and ability to read engineering docs.

Responsibilities

• Review customer complaints and service data to determine risk levels and codes.
• Conduct complaint investigations and perform root cause analysis.
• Analyze data from quality systems to identify trends and issues.
• Prepare investigation summaries, reports, and recommendations.
• Review investigation reports for GMP compliance gaps.
• Support development and implementation of CAPA.
• Drive continuous improvement and process control activities.
• Conduct data analysis using statistical tools and quality methods.
• Collaborate cross-functionally to improve product quality and compliance.

Skills

Analytical thinking

Problem solving

Statistical tools (Minitab)

CAPA processes

Engineering documentation reading

MS Office (Excel/Word/PowerPoint)

Data analysis

Education

Bachelor's degree in engineering or equivalent

Tools

Minitab

Quality management systems software

Job description

Katalyst CRO in Michigan is seeking a Quality Complaint Investigation professional to support complaint investigations, CAPA activities, and continuous improvement in a regulated medical device environment. The role involves analyzing quality data, performing root cause analyses, reviewing GMP documentation, and ensuring compliance with FDA QSR 21 CFR 820.

You will collaborate cross-functionally, prepare investigation summaries, and drive corrective actions to improve product quality and