Quality Assurance Manager

1 week ago

Bloomfield, Connecticut, United States Millstone Medical Full time
About the Role

We are seeking a highly skilled Quality Assurance Manager to join our team at Millstone Medical. As a key member of our quality team, you will be responsible for ensuring that our medical device testing and laboratory services meet the highest standards of quality and compliance.

Key Responsibilities
  • Quality Management System (QMS):
    • 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.
Requirements
  • Bachelor's degree in Engineering, Life Sciences, Quality Management, or a related field.
  • Minimum of 5 years of experience in Quality, Management, Engineering or Microbiology based testing, preferably in the medical device or laboratory sectors.
  • Attention to detail with the ability to recognize and communicate potential issues
  • Advanced math skills - basic statistics
  • Advanced ability to create Excel, PowerPoint and Word documents
  • Ability to write or re-write procedures, forms and master batch records
  • Excellent organizational skills with the ability to provide supervision and leadership
  • Excellent interpersonal skills
  • Knowledge of standards and requirements related to FDA/GMP compliance
  • Knowledge of standards and requirements related to ISO 17025 compliance preferred
  • Knowledge of standards and requirements related to ISO 13485 compliance preferred
  • Knowledge of medical device testing specifically microbiology based testing or medical device manufacturing
  • ASQ or RABQSA certification preferred (i.e. CQE, CQA, Lead Auditor)
  • ISO 13485 Lead Auditor certification or equivalent preferred
  • ISO 17025 Lead Auditor certification or equivalent preferred
  • Strong experience with audit processes and CAPA management.
  • Excellent problem-solving skills and attention to detail.
  • Strong communication and leadership skills.
  • Ability to work effectively in a team environment and collaborate with cross-functional teams.

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