Sr. Quality Assurance Manager

Contract Professionals, Inc; Michigan; On-site; USD 150,000 - 170,000; Full time

Job summary

Contract Professionals, Inc. in Clinton Township, MI seeks a Senior Quality Assurance Manager to lead the QMS, ensure ISO 13485 and FDA compliance, and drive regulatory readiness across the organization.

You will oversee CAPA, audits, validations, and customer investigations while mentoring the quality team in a highly regulated medical device environment. As a senior leader, you will partner with Engineering, Manufacturing, and Operations to elevate product quality and compliance, driving

Qualifications

• 8+ years of Quality experience in regulated manufacturing.
• Experience leading QA teams and quality initiatives.
• Expertise in ISO 13485 and FDA 21 CFR Part 820 / QMSR.

Responsibilities

• Lead and continuously improve the company's Quality Management System.
• 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

QMS

Regulatory compliance

CAPA & Audits

Medical device manufacturing

Continuous improvement

ITAR awareness

Six Sigma / CQE/CQA

People leadership

Job description

Senior Quality Assurance Manager Clinton Township, MI Direct Hire | Full-Time | On-Site $150, 000–$170, 000 + Excellent Benefits

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
• Highly Preferred: Plastic injection molding experience
• ITAR experience
• ASQ Certification (CQE/CQA) or Six Sigma