16 days old

Manager, Supplier Quality

Abbott
St Paul, MN 55102

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

POSITION OVERVIEW:

The Supplier Quality Manager is responsible for leading the Supplier Quality department that works with engineering and suppliers to ensure that suppliers can correctly manufacture components for complex medical device products in compliance with regulatory requirements.
 

Directing all activities within the Supplier Quality Function including:

  • Quality Assurance (Supplier Quality)
  • CAPA – Supplier corrective action management; Metrics
  • NCMRs – Material Review Board and NCMR
  • Auditing – QMS, Product and Process Controls
  • Statistical Techniques; Part Qualifications
  • Provide support and guidance in preparation of responses to Internal, Division, Corporate and external audits
  • Assure compliance with all appropriate regulatory requirements
  • Assist in bringing new products to market in a timely manner and within regulatory requirements

    PRIMARY JOB SCOPE:

    Provide strategic and functional leadership of Supplier Quality activities ensuring compliance to applicable regulatory requirements, part specifications and Quality Agreements.  Manage a staff of Supplier Quality Engineers to support the supplier quality role and responsibilities.  Ensure that suppliers perform and document the appropriate engineering approach for activities such as qualification and validation of processes, methods, and equipment, and assist in these efforts, as appropriate, to ensure safe, efficacious and quality product are supplied to Abbott in accordance with regulatory and business requirements.

    CORE JOB RESPONSIBILITIES:

    The Manager, Supplier Quality is responsible for performing the following activities:

    • Monitor supplier performance and report supplier quality trend data to upper management.
    • Lead supplier continuous improvement plans and activities.
    • Serve as a Subject Matter Expert during Internal and External inspections.
    • Establish and maintain successful cross-functional relations with Design & Development, Engineering, Manufacturing, Operations, Quality Control, Quality Assurance, and Quality Systems departments.
    • Manage Supplier Quality budget.
    • Lead the development of the Supplier Quality Engineering staff, providing growth plans and professional guidance, as appropriate.
    • Evaluate and approve supplier requested changes or improvements. This activity may include changes such as the identification and/or approval of new supplier to provide an alternate material, site change, and manufacturing process changes.
    • Develop and consistently execute a quality strategy for suppliers to assure business objectives are met while assuring compliance to applicable regulatory requirements and Abbott policies.
    • Direct the Supplier QE team to ensure that the commitments of the Quality Agreements are being fulfilled and help facilitate resolution in cases when they are not.
    • Lead and participate on cross-functional teams to support suppliers, including active participation in Business Management Reviews as necessary.
    • Ensure timely handling of supplier exceptions with impact on product quality, safety, efficacy and impact to the regulatory filing. 
    • Lead the supplier quality team on timely and compliant handling of NCMRs and SCARs.
    • Provide a Quality Assurance service with regards to guidance on validation strategies; guidance on product, process, equipment, analytical which may or may not require a re-validation.
    • Develop and maintain an appropriate Quality Management Review program and Quality Performance Measurements for Suppliers, that identify and address quality, operational, and organizational issues.
    • Promote continuous improvement, innovation, simplification aligned with Abbott and division strategy.

      MINIMUM QUALIFICATIONS:

      • 6 to 10 years of experience preferably in a quality/technical area or clinical laboratory
      • Demonstrated leadership experience through formal and/or informal assignments
      • Knowledge of regulations and standards affecting IVDs, medical devices and/or biologics manufacturing (e.g. QSR, ISO, EN Quality System Requirements).

        PREFERRED QUALIFICATIONS:

        • 10+ years of experience in Quality Assurance/Regulatory in a company with medically focused manufacturing environment is strongly desired.
        • 6 years of experience in Supplier quality related functions.
        • 4+ years of experience in management of direct resources or cross functional teams.
        • Demonstrated experience with development, implementation and management of quality system procedures/practices.
        • Proven ability to work successfully cross-functionally and collaboratively to problem solve, initiate and manage projects, influence internal and external groups and provide leadership from a quality perspective.
        • Highly developed written, oral and interpersonal skills,
        • Strong statistical application experience and proficient use of various software applications such as MS Word, Excel, Access and statistical analysis tools like Minitab.
        • Knowledge of Medical Industry Design Controls, V&V, operations and manufacturing practices is desirable.
        • Up to 30% local and global travel

          EDUCATION

          • Bachelor’s Degree required, preferably in Electrical or Mechanical Engineering, Bioengineering or other science disciplines.
          • Master’s Degree preferred in MBA or MS Engineering or MS Quality or MS Industrial Technology  

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            Travel: Yes, 25 % of the Time
            Medical Surveillance: Not Applicable
            Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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Posted: 2019-09-04 Expires: 2019-10-06

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Manager, Supplier Quality

Abbott
St Paul, MN 55102

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