Quality Assurance Manager

3 days ago


West Bloomfield Township, Michigan, United States Millstone Medical Full time
Quality Assurance Manager

Millstone Medical Testing is seeking a highly skilled Quality Assurance Manager to join our team. As a Quality Assurance Manager, you will be responsible for managing our Quality Management systems at all Millstone Medical Testing locations.

Key Responsibilities:
  • Maintain the Quality Management System in compliance with ISO 13485 and ISO 17025 standards.
  • Ensure that all processes, documentation, and records adhere to the requirements of these standards.
  • Regularly review and update quality policies, procedures, and manuals.
Audit and Compliance:
  • Plan, coordinate, and execute internal and external audits in line with ISO 13485 and ISO 17025.
  • Ensure compliance with relevant regulatory and customer requirements.
  • Prepare for and participate in third-party audits and inspections, ensuring all findings are addressed promptly.
CAPA (Corrective and Preventive Action):
  • Lead the CAPA program, including the identification, investigation, and resolution of quality issues.
  • Implement effective corrective and preventive actions, and monitor their effectiveness.
  • Drive continuous improvement initiatives based on CAPA findings and other quality data.
Document Control:
  • Oversee the management of quality-related documentation, including the control of procedures, work instructions, forms, and records.
  • Ensure proper change management processes are followed for all quality documents.
Supplier Quality Management:
  • Manage the qualification and performance monitoring of suppliers and subcontractors.
  • Conduct supplier audits to ensure compliance with quality standards and regulatory requirements.
Team Leadership:
  • Lead and mentor the quality assurance team, providing guidance on quality issues and promoting a culture of continuous improvement.
  • Provide training and support to staff on quality standards, procedures, and best practices.
Customer Interaction:
  • Act as the primary point of contact for quality-related matters with customers.
  • Address customer complaints and ensure effective resolution in a timely manner.

Millstone Medical Testing is an equal opportunity employer and welcomes applications from diverse candidates. We offer a competitive compensation package, including medical, dental, and vision benefits, as well as a 401(k) plan with match. If you are a motivated and detail-oriented individual with a passion for quality assurance, we encourage you to apply for this exciting opportunity.



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