Senior Manager of Quality

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Senior Manager of Quality

  • Specialty:

    Engineering
  • Title:

    Senior Manager of Quality
    • City:

      Waltham
    • State:

      MA
    • Zip Code:

      02451-
  • Start date:

    12-04-2019
  • Status:

    Closed
  • Assignment Type:

    Direct Hire
  • Job Id:

    51678

Description

Senior Manager of Quality

Responsibilities:

  • Ensure a compliant Quality Management System (QMS) and the process necessary to successfully produce Class I Medical Device (Diagnostic) products (FDA, ISO 13485, etc.). 
  • Outline and implement improvements to Quality System and processes as needed.
  • Provide Quality Team support of enterprise excellence culture by promoting Good Manufacturing practices and supporting achievement of annual site objectives.
  • Ensure all Risk Management activities are executed and maintained according to all regulatory standards.
  • Represent Quality for manufacturing transfers and quality plan initiatives. 
  • Prepare for and participate in FDA, ISO and Customer audits as the main contact.
  • Manage routine QMR process and participate in the MOR process in conjunction with the Global Regulatory department, work to facilitate domestic and international regulatory requirements.
  • Manage the site corrective and preventative action process, analyze data from Nonconformities, Deviations, CAPA and maintain all data.
  • Collect and analyze data required by regulatory agencies and by internal requirements.
  • Maintain a QMS training program and administer as needed to be effective.
  • Manage Incoming Inspection and the Material Review Board Process.
  • Oversee the responsibilities in association with final product release.
  • Manage the internal audit schedule and process; maintain all records of internal audits. 

Qualifications

  • Bachelor’s degree in Engineering or relevant discipline 
  • 8+ years Quality experience in an ISO 13485 environment 
  • 3+ years experience leading a team
  • Experience working in a manufacturing and/or production environment
  • Good understanding of customers, products, and regulatory compliance
  • Understands the customer and required compliance regulations for our products and processes

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