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Quality Assurance Professional

Company: W.L. Gore
Location: Flagstaff
Posted on: September 12, 2019

Job Description:

About Us: Gore is a materials science company focused on improving lives through discovery, product innovation and rewarding careers for our Associates. Learn More.

About the Industry: Saving lives and improving the quality of life for patients is at the core of everything we do. This meaningful work gives purpose to our lives and inspires us to create solutions that make a difference in the lives of others. Learn More.

About the Role: W. L. Gore is seeking a Quality Assurance Professional for our Flagstaff, Arizona facility. In this role, you will work on a cross-functional team to support day-to-day manufacturing and plant operations, including executing the NCR, CAPA and other quality systems, addressing product issues, defining and implementing effective corrective actions, and monitoring post-implementation effectiveness.

Responsibilities:


  • Supporting the day to day manufacturing process including problem solving, CAPA and nonconformance investigations and responding with appropriate risk based decision making
  • Providing hands-on coordination and support for execution of the nonconforming product (NCR) and corrective and preventive actions (CAPA) processes
  • Providing hands-on coordination and investigation of failure investigations (FIR) from initiation to completion to ensure time-sensitive activities, documentation and approvals are completed
  • Ensuring constant audit readiness for product line and assist in audit preparation and coordination to deliver successful audit results
  • Working and communicating with the QA and cross functional teams as well as non-QA organizations across the product line and MPD to support a quick and robust decision-making process in support of quality system requirements
  • Supporting prioritized activities, including NCR, CAPA, FIR and operational improvements
  • Helping manufacturing with daily issues related to quality system requirements
  • Training and educating others on quality-system requirements and good documentation practices to help ensure compliance
  • Participating in and performing quality system compliance audits
  • Enhancing quality systems (including software implementation and validation)
  • Advising, collaborating with, and influencing cross functional teams (e.g. Manufacturing, Engineering, Operations, Environmental Monitoring, Maintenance and Calibration, Regulatory, Document Control, etc.
  • Providing hands-on mentoring and guidance for situational compliance issues
  • Developing procedures and initiating change documentation in support of new and existing products
  • Developing quality reports and metrics to support assessments of quality system effectiveness and product line goals and objectives

    Required Qualifications:

    • Bachelor's degree, OR a 2-year degree plus at least 6 years of pharmaceutical OR medical device experience in a quality, manufacturing or operations role
    • At least 4 years of Quality Assurance related experience supporting combination product medical devices or similar experience in the pharmaceutical industry
    • Demonstrated working knowledge of FDA quality system regulations
    • Excellent written and oral communication skills
    • Strong interpersonal and influence skills
    • Conflict resolution skills

    • Ability to:
      • Work independently, as well as part of a diverse team
      • Set and meet aggressive timelines

        Desired Qualifications:

        • Lead Auditor Certification
        • Experience supporting various manufacturing processes
        • Strong knowledge of E1 and PLM systems

          What We Offer: At Gore, we offer comprehensive, competitive rewards in the form of compensation and benefits. Among these are work-life balance and sports programs, 401(k) Plan with a gift, Associate Stock Ownership Plan, Health & Well-being program with full health plan, and a flexible working program. Within Gore, you will find a unique culture, diversity, equity, and inclusion initiatives, and opportunities for growth and development.

          Learn more about: benefits, diversity, and growth & development.

          We believe in the strength of a diverse workforce and inclusive work environment. In support of our values and continued success we are proud of Associates around the world who support an inclusive work environment, strive to reflect the diversity of the communities where we operate, and ensure all Associates and external partners are treated with fairness, dignity, and respect.

          Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening.

          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.

          Gore is a M/F, Disabled and Vet EEO/AA employer. (Applies to all positions in the U.S.)

          gore.com/change-life

          Our Talent Acquisition Team will be pleased to answer your questions via contact us.

Keywords: W.L. Gore, Flagstaff , Quality Assurance Professional, Accounting, Auditing , Flagstaff, Arizona

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