Senior Quality Assurance Manager

Contract Professionals, Inc.; Clinton Charter Township (MI); On-site; USD 110,000 - 160,000; Full time

Job summary

Contract Professionals, Inc. is seeking a Senior Quality Assurance Manager in Michigan to lead the Quality strategy across the organization in a highly regulated medical device environment. You will own the QMS, drive regulatory compliance, CAPA, audits, and continuous improvement initiatives.

The role requires 8+ years in regulated manufacturing, proven leadership of Quality teams, and deep experience with ISO 13485, FDA 21 CFR Part 820 / QMSR, CAPA, IQ/OQ/PQ, and audits.

Qualifications

• 8+ years of Quality experience in a regulated manufacturing environment.
• Leadership experience managing Quality teams
• Strong experience with: ISO 13485, FDA 21 CFR Part 820 / QMSR, CAPA, Internal & External Audits, Validation (IQ/OQ/PQ), Quality Management Systems
• Medical device manufacturing experience
• ASQ Certification (CQE/CQA) or Six Sigma

Responsibilities

• Lead and continuously improve the company's Quality Management System (QMS).
• Ensure compliance with ISO 13485, FDA 21 CFR Part 820/QMSR, ITAR, and customer requirements.
• Oversee CAPA, nonconformances, customer complaints, audits, validations, and regulatory compliance.
• Serve as the primary Quality representative during customer, certification, and regulatory audits.
• Lead, mentor, and develop the Quality team while partnering with Engineering, Manufacturing, and Operations.
• Drive continuous improvement initiatives that enhance product quality, compliance, and operational performance.

Skills

Quality leadership

Regulatory compliance

Medical device manufacturing

ISO 13485

FDA 21 CFR Part 820 / QMSR

CAPA

Internal & External Audits

IQ/OQ/PQ

QMS

Team leadership

Job description

Are you an experienced Quality leader with a strong background in medical device manufacturing, ISO 13485, FDA compliance, and Quality Management Systems?

We're partnering with an innovative manufacturer seeking a Senior Quality Assurance Manager to lead Quality strategy, regulatory compliance, and continuous improvement initiatives across the organization. This is an excellent opportunity to make a significant impact while leading a talented quality team in a highly regulated manufacturing environment.

What You'll Do

• Lead and continuously improve the company's Quality Management System (QMS).
• Ensure compliance with ISO 13485, FDA 21 CFR Part 820/QMSR, ITAR, and customer requirements.
• Oversee CAPA, nonconformances, customer complaints, audits, validations, and regulatory compliance.
• Serve as the primary Quality representative during customer, certification, and regulatory audits.
• Lead, mentor, and develop the Quality team while partnering with Engineering, Manufacturing, and Operations.
• Drive continuous improvement initiatives that enhance product quality, compliance, and operational performance.

What We're Looking For

8+ years of Quality experience in a regulated manufacturing environment

Leadership experience managing Quality teams

Strong experience with:

• ISO 13485
• FDA 21 CFR Part 820 / QMSR
• CAPA
• Internal & External Audits
• Validation (IQ/OQ/PQ)
• Quality Management Systems

Medical device manufacturing experience

• ASQ Certification (CQE/CQA) or Six Sigma