Senior QA Leader: QMS & Regulatory Compliance

TriMas Corporation; Michigan; On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Short-Term Disability

Long-Term Disability Insurance

Paid Time Off

Retirement Program

Job summary

Omega Plastics Inc. seeks a Sr. Quality Assurance Manager to lead the Quality Management System across design, development, manufacturing and post-market activities.

This on-site role is based at Clinton Township, MI and reports to the leadership team. You will drive regulatory compliance (FDA 21 CFR Part 820, ISO 13485), coordinate external audits, and mentor QA staff. Requires a technical degree and 8+ years in regulated QA with leadership experience.

Qualifications

• Bachelor's degree in a technical discipline or equivalent experience.
• 8+ years experience with FDA 21 CFR Part 820, ISO 13485, ITAR, CAPA, audits, validation, and Quality Management Systems.
• 8+ years of progressive Quality Assurance experience in a regulated ISO13485 plastic injection manufacturing environment.
• 5+ years experience in a leadership role for a quality team

Responsibilities

• Provide strategic leadership for the QMS ensuring compliance with FDA 21 CFR Part 820, ISO 13485 across product lifecycle.
• Lead external quality audits as Management Representative and coordinate audits with customers and regulatory bodies.
• Direct management of Quality Assurance personnel and the Quality Control Manager; drive continuous improvement.
• Ensure on-site presence 5 days a week at Clinton Township, MI.

Skills

Leadership experience

Quality Management

Regulatory compliance

Education

Bachelor's degree in a technical discipline

Job description

Omega Plastics Inc. seeks a Sr. Quality Assurance Manager to lead the Quality Management System across design, development, manufacturing and post-market activities.

This on-site role is based at Clinton Township, MI and reports to the leadership team. You will drive regulatory compliance (FDA 21 CFR Part 820, ISO 13485), coordinate external audits, and mentor QA staff. Requires a technical degree and 8+ years in regulated QA with leadership experience.