Quality Assurance Engineer – Medical Devices

TriMas Corporation; Michigan; On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Job summary

Omega Plastics Inc is seeking a Quality Engineer to lead compliance and QA engineering for medical devices and components, developing validation programs and quality plans to ensure safety and customer satisfaction throughout the product lifecycle.

The role emphasizes IQ/OQ/PQ protocol creation, risk assessment, and adherence to ISO 13485 and FDA requirements, with on-site collaboration and strong documentation practices.

Qualifications

• Requires degree in engineering, life sciences, or related field with knowledge of regulatory standards like ISO 13485 and FDA Part 820.
• Strong communication skills: verbal, written, technical presentations.
• Experience with statistics (SPC, Red X) and production quality systems.

Responsibilities

• Develop IQ/OQ and PQ protocols and summary reports.
• Support risk assessment for clients and internal teams; coordinate with supplier base.
• Perform risk analysis in accordance with ISO-14971 and FMEA principles.
• Coordinate quality efforts with clients for specific quality requirements.
• Support internal audits and ensure 21 CFR 820 and ISO 13485:2016 compliance.

Skills

Quality Assurance

Risk assessment

Regulatory compliance

Process validation

Documentation

Education

Engineering or life sciences degree

Tools

ISO 13485

FDA 21 CFR Part 820

FMEA

Job description

Omega Plastics Inc is seeking a Quality Engineer to lead compliance and QA engineering for medical devices and components, developing validation programs and quality plans to ensure safety and customer satisfaction throughout the product lifecycle.

The role emphasizes IQ/OQ/PQ protocol creation, risk assessment, and adherence to ISO 13485 and FDA requirements, with on-site collaboration and strong documentation practices.