W1siziisimnvbxbpbgvkx3rozw1lx2fzc2v0cy9jbhnyzxnvdxjjaw5nig5ldy9qcgcvbmv3lwjhbm5lci1kzwzhdwx0lwpvyi5qcgcixv0

Quality Assurance Manager

  • Location

    Burlington, United States

  • Sector:

    Quality & Validation

  • Job type:

    Permanent

  • Salary:

    $120,000 - $140,000

  • Contact:

    Callum Sparkes

  • Contact email:

    callum.sparkes@catalystcareers.com

  • Job ref:

    60288

  • Published:

    9 days ago

  • Expiry date:

    2021-09-10

  • Consultant:

    Callum Sparkes

An opportunity for a high performing quality professional to take full responsibility and control of an existing Quality Management System for a small company working closely with senior leadership. With an FDA approved product on the market and significant VC funding, the high energy environment is a great place for someone to utilize and develop their quality skills.

Core Responsibilities:
  • Actively manage the CAPA process, coordinating cross functional efforts in developing the CAPA plan, corrective actions and effectiveness verifications.
  • Manage collaboratively with R&D and Operations for the manufacturing process validation and oversee the equipment IQ/OQ/PQ activities and documentation.
  • Assure that the Quality System is in compliance with applicable standards and regulations, including FDA Quality under ISO:13485.
  • Coordinate internal and external audit program and oversee the Corrective Action program.
  • Responsible to recommend corrective action to the Quality System based upon internal or external quality reports.
  • Participate in the Management review duties
  • Manage suppliers and OEMs, perform periodic audits abd manage the document change control process.
  • Support and coordinate complaint handling, serve as a member of the Quality Review Team to assess adverse events reportability, develop health hazard evaluation and perform US MDR reporting as necessary.
  • Develop, refine, and document quality control test and inspection procedures.
  • Develop the comprehensive process validation plan that encompass the entire production cycle from raw material receiving to finished product release, including any steps performed at OEM.
Experience Required to be considered:
  • At least 8 years' medical industry experience in an ISO:13485 regulated quality function, including management experience.
  • BS in scientific/engineering or relevant discipline
  • Thorough understanding of FDA QSR regulations, with a focus n CAPA, complaint handling and process control
  • Thorough knowledge of product development process, design controls and a strong command of IQ, OQ, PQ protocols.