10 days old

Sr QA Manager

Danaher
McGrath, MN 56350

POSITION SUMMARY:

Manage teams responsible for maintaining, monitoring and developing non-conformance, change management processes and related QA deliverables for validation of equipment used to develop, manufacture and control Cepheid products, in conjunction with Company objectives and Regulatory requirements.

Mentors and provides guidance and support to the QA teams. Provide guidance trough interactions with other functional areas and operating enteties.

ESSENTIAL JOB RESPONSIBILITIES:

  • Manage through teams with direct reporting managers, the responsibility of processes such as NC, change management and QA project support
  • Manage through teams with direct reporting managers; validation process and ensure good validation practices across Cepheid Solna
  • Manage through teams with direct reporting managers, the responsibility of processes such as NC, change management and QA project support
  • Support the implementation of new  production lines, or modifications in the installation, calibration, use or maintenance of equipment.
  • Control and approve validation strategies, protocols and reports
  • Ensure that a risk based approach is used for management of processes
  • Ensure timely achievements of team deliverables according to annual quality plan
  • Participate to the definition of annual quality goals and quality plans related to validation, calibration, NC

    MINIMUM REQUIREMENTS:

    Education or Experience (in years): 

    • Bachelor's degree with 9+ years of experience or Master´s degree with 7+ years of experience
    • Excellent skills in written and verbally (English required €“ Swedish preferred)

      Knowledge and skills: 

      • Experience in validation of complex systems
      • Knowledge of risk management tools (FMEA, FTA etc..)
      • ISO 13485

        Physical requirements/abilities: 

        • N/A

          Other: 

          • High adaptability and flexibility
          • Multi-tasking ability
          • Strong leadership and excellent communication skills
          • Collaborative
          • Careful and thorough

            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":"Biotechnology

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

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Sr QA Manager

Danaher
McGrath, MN 56350

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