Quality Assurance Manager

Contract Professionals, Inc.; Clinton Charter Township (MI); On-site; USD 120,000 - 190,000; Full time

Job summary

Contract Professionals, Inc. is partnering with a medical device manufacturer to hire a Senior Quality Assurance Manager in the United States. This role will lead quality strategy, regulatory compliance, and continuous improvement across the organization.

You will drive the QMS, oversee CAPA and audits, and serve as the primary quality representative during regulatory activities, while mentoring the quality team and collaborating with Engineering, Manufacturing, and Operations.

Qualifications

• 8+ years of quality leadership in a regulated manufacturing environment.
• Proven success leading quality teams.
• Strong experience with ISO 13485, FDA 21 CFR Part 820/QMSR, CAPA, audits and validation.
• Medical device manufacturing background required.
• ASQ CQE/CQA or Six Sigma certification preferred.

Responsibilities

• Lead and continuously improve the Quality Management System (QMS).
• Ensure regulatory compliance with ISO 13485, FDA 21 CFR Part 820/QMSR, ITAR, and customer requirements.
• Oversee CAPA, nonconformances, customer complaints, audits, and validations.
• Serve as primary Quality representative during customer, certification, and regulatory audits.
• Mentor and develop the Quality team and partner with Engineering, Manufacturing, and Operations.

Skills

Leadership

ISO 13485

FDA 21 CFR Part 820/QMSR

CAPA process

Audits (internal & external)

Validation IQ/OQ/PQ

Quality Management Systems

Education

ASQ CQE/CQA or Six Sigma certification

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