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. partners with a leading medical device manufacturer to identify a Senior Quality Assurance Manager.

This role leads the Quality strategy, regulatory compliance, and continuous improvement across the organization, guiding a skilled quality team in a highly regulated environment. The position focuses on maintaining ISO 13485, FDA compliance (21 CFR Part 820 / QMSR), CAPA, audits, and ongoing quality program enhancements to ensure top-tier product quality and regulatory

Qualifications

• 8+ years of quality experience in a regulated manufacturing environment.
• Leadership experience managing quality teams.
• Experience with ISO 13485, FDA 21 CFR Part 820 / QMSR, CAPA, audits, and validations.

Responsibilities

• Lead and continuously improve the company's Quality Management System (QMS).
• Ensure compliance with ISO 13485 and FDA requirements.
• Oversee CAPA, nonconformances, customer complaints, audits, validations, and regulatory compliance.
• Serve as the primary Quality representative during audits and regulatory activities.
• Lead, mentor, and develop the Quality team with cross-functional collaboration.
• Drive continuous improvement to enhance product quality and operations.

Skills

Quality leadership

Regulatory compliance

QMS

Audits

CAPA

IQ/OQ/PQ

ISO 13485

FDA 21 CFR Part 820/QMSR

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