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Regulated Quality Assurance Professional

Company: W.L. Gore & Associates
Location: Flagstaff
Posted on: July 6, 2024

Job Description:

About the Role: We are looking for a Quality Assurance Professional to join the Gore Medical Components Quality team. In this role, you will have the opportunity to support our business by ensuring our processes are effective and aligned with customer and external requirements. This role includes providing critical day-to-day quality support of our functional teams and development of a future-state quality system.

This position will be located at our facility in Flagstaff, Arizona, with the possibility of a hybrid remote work arrangement, depending upon the responsibilities of the role and business needs.


  • Translate quality standards and customer requirements into productive procedures, practices, and behaviors
  • Provide guidance, interpretation, and assistance in application of quality system procedures and practices
  • Influence associates to consistently think and act (proactively and reactively) to support high-quality products, while providing the context for, and the value of, performing various activities
  • Drive improvements to increase the effectiveness of quality processes and controls
  • Review and approve quality related documents (corrective actions, non-conformances, changes, etc.)
  • Write defensible rationales that follow good technical writing practices (background, supporting evidence, broader justification and a decisive conclusion)
  • Utilize project management best practices to plan, execute, and close projects while actively seeking diverse perspectives as inputs
  • Create detailed project plans to provide clear timelines and expectations
  • Serve as a change agent by promoting, championing, enabling, and supporting changes made in the organization

    Required Qualifications:
    • Minimum of 10 years of experience in roles supporting a medical device manufacturing environment, including a Minimum 5 years in a Quality Assurance (QA) capacity
    • Experienced implementing quality system requirements within an ISO certified manufacturing environment (e.g. ISO9001, ISO13485)
    • Demonstrated knowledge of relevant standards (eg ISO9001, ISO13485)
    • Demonstrated oral and written communication skills, including use of virtual collaboration and communication tools
    • Demonstrated ability to champion complex projects to timely and effective completion utilizing project best practices and project management tools
    • Demonstrated ability to influence and collaborate across multiple functions (technical, engineering, operations, quality)
    • Demonstrated ability to work independently and navigate ambiguity
    • Ability to apply a systematic thought process during application of procedures or when considering changes; ability to consider broader implications
    • Ability to travel up to 10%

      Desired Qualifications:
      • ASQ Certification(s) (e.g. Manager of Quality/Organizational Excellence (CMQ/OE), Certified Quality Auditor (CQA), Certified Quality Engineer (CQE))
      • Experience participating in quality audits as an audit team member, or in support of customer/external audits
      • Experience applying risk management tools such as Failure Mode Effects Analysis (FMEA), Fault Tree Analysis (FTA), or risk ranking and filtering

        Hybrid Working Arrangements are permitted for Associates in the continental United States (US) and Canada, with appropriate approval and compliance with Gore's hybrid working policies, from the country in which they are employed.

        What We Offer: Our success is based on the capability and creativity of our Associates, and we are proud to offer a comprehensive and competitive total rewards program that supports your everyday and helps you build your tomorrow.

        We provide benefits that offer choice and flexibility and promote overall well-being. And in keeping with our belief that every Associate should share in the collective success of the enterprise; we provide a distinctive Associate Stock Ownership Plan in each country as well as potential opportunities for "profit-sharing". Learn more at gore.com/careers/benefits

        We believe in the strength of a diverse and inclusive workplace. With diverse perspectives, ideas and experiences, we uncover new possibilities and make a greater impact in the world. We are proud of Associates for building on our rich history of innovation, upholding our values and supporting an inclusive work environment where we treat each other and our external partners with fairness, dignity and respect.

        Gore is an equal opportunity employer. We welcome all applications irrespective of race, color, religion, sex, gender, national origin, ancestry, age, status as a qualified individual with a disability, genetic information, pregnancy status, medical condition, marital status, sexual orientation, status as a covered veteran, gender identity and expression, and any other characteristic protected by applicable laws and regulations.

        Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening. Gore will consider qualified applicants with criminal histories, e.g., arrest and conviction records, in a manner consistent with the requirements of applicable laws.

        Gore requires all applicants to be eligible to work within the U.S. Gore generally will not sponsor visas unless otherwise noted on the position description.

        Our Talent Acquisition Team welcomes your questions at gore.com/careers/contact

Keywords: W.L. Gore & Associates, Flagstaff , Regulated Quality Assurance Professional, Other , Flagstaff, Arizona

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