10 days old

Supplier Quality Manager

Clark, CO 80428

Title:                                   Supplier Quality Manager (Manager, Quality Assurance)

Level:                                  M2

Department:                      QA

Reporting To:                    Manufacturing & Supplier Quality Manager  


  • Management for all BCII logistics Quality activities related to receiving and Goods inwards processes.
  • Management of all supplier assurance activities to include:
  • Establishment of audit schedule and auditing suppliers
  • Supplier Liaison and evaluation
  • Supplier specification maintenance
  • Management of Supplier Change notifications (SCN) and Supplier Corrective Actions (SCARs), as necessary.
  • Maintain supplier file documentation including ISO certifications.
  • Management of incoming inspection activities and establishment of ship to stock programme.  
    • Management of CCF processing activities to include:
    • All BCII documentation updates on the CCF database.
    • Software updates on the BEC analysers through CCF.
    • Printed lables, IFUs, Parameter CD and Reagent Guide DVD through CCF
    • Periodic Review process management
    • Global documentation review process management
    • Management of ERP system updates to include:
    • Development and maintenance of BOMs.
    • Item Master file maintenance.
      • Maintain a strong ongoing knowledge, as well as QS compliance with the latest agency regulatory requirements (e.g. US FDA, Cfda, Health Canada) and applicable standard requirements (e.g. ISO certification).
      • Provision of excellent internal and external, where appropriate, customer satisfaction by continually striving to improve service
        • Ensuring all Software/equipment used in your area with GMP impact are validated/calibrated.
        • Involvement in Internal Auditing process.
        • Quality Assurance responsibilities on design projects, if applicable.
          • Management of, communication with and development of staff to include -  Objective Setting and performance of 1 to 1 discussions and formal annual appraisals.
          • Training area personnel on procedures, cGMPs and documentation control.
            • Team work €“ Encouragement of team-work within own areas as well as involvement, where appropriate, in plants cross-functional problem solving initiatives.
              • Role is viewed as lead or expert in the area of US FDA and ISO13485 / IVDD/IVDR, Cfda, Health Canada, HPRA, JPAL and GMP requirements for IVD reagents, constantly promoting awareness of best industry practices and making appropriate decisions on a daily basis using the Manufacturing and Supplier Quality Manager as the final arbitrator on critical quality decisions.
                • Is key to developing new technical staff on supplier quality initiatives and assists understanding and rollout of quality initiatives across the company.
                  • Provide meaningful Quality measurement while ensuring that in-house or external Quality issues are effectively prioritised and acted upon in a timely manner.
                  • Enforce strict House keeping standards in all areas under their control.
                  • Ensure that own area procedures are reviewed as appropriate and are updated and correct.
                  • Responsibility for all departmental issues related to the Environment, Health & Safety.
                  • Ensuring that all activities of the BCII Supplier and Logistics Quality are completed while complying with relevant procedures.
                    • Must keep manager informed.
                    • Provides regular reports as deemed necessary by senior management.
                    • Education/ Experience:

                      • B.Sc., M.Sc., or PhD in chemistry, biochemistry, biology or other relevant technical field.
                      • At least 9 years experience in Q&RA in an FDA regulated industry with at least 2 years management experience.
                      • Strong interpersonal and communication skills are an essential prerequisite with the ability to influence.

                        Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The €œEEO is the Law€ poster is available here.","industry":"Medical Device


Posted: 2020-05-21 Expires: 2020-06-20

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Supplier Quality Manager

Clark, CO 80428

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