Senior Quality Engineer - ISO13485/21 CFR 820 NPI CAPA Lead

TriMas Corporation; Clinton Charter Township (MI); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Paid Time Off

Retirement Program

Job summary

A manufacturing company is seeking a Senior Quality Engineer located in Clinton Township, Michigan. The role includes leading Non-Conformance activities, developing validation protocols, and supporting quality management systems. Candidates should have a Bachelor's degree in Biomedical or related engineering, with at least one year of relevant experience in quality assurance. Knowledge of ISO-13485 and 21 CFR-820 is essential. Benefits include medical, dental, vision insurance, flexible spending accounts, and a retirement program.

Qualifications

• Bachelor’s degree or equivalent in related engineering field.
• At least 1 year of experience in quality assurance or related positions.
• Knowledge of ISO-13485 and 21 CFR-820 compliance.

Responsibilities

• Lead activities for Non-Conformances, CAPA, and customer complaints.
• Develop IQ/OQ/PQ Validation protocols and review documentation.
• Support Quality Management System development.
• Conduct internal audits and collaborate to resolve findings.

Skills

ISO-13485 standards

Quality Management Systems

Risk management tools

Measurement System Analysis

Corrective and Preventive Action processes

Minitab

Education

Bachelor’s degree in Biomedical Engineering or related field

Job description

A manufacturing company is seeking a Senior Quality Engineer located in Clinton Township, Michigan. The role includes leading Non-Conformance activities, developing validation protocols, and supporting quality management systems. Candidates should have a Bachelor's degree in Biomedical or related engineering, with at least one year of relevant experience in quality assurance. Knowledge of ISO-13485 and 21 CFR-820 is essential. Benefits include medical, dental, vision insurance, flexible spending accounts, and a retirement program.