W. L. Gore & Associates

Quality Assurance Professional


PayCompetitive
LocationElkton/Maryland
Employment typeFull-Time

This job is now closed

  • Job Description

      Req#: 712701
      About the Role: We are looking for a Quality Assurance Professional to join the General Medical Products Quality Assurance team to work with cross-functional teams 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. This position will be located at one of our facilities in Elkton, Maryland, with the possibility of a hybrid remote work arrangement, depending upon the responsibilities of the role and business needs. Responsibilities:- Support the day to day manufacturing process including problem solving, CAPA and nonconformance investigations and respond with appropriate risk based decision making - Provide hands-on coordination and support for execution of the nonconforming product (NCR) and corrective and preventive actions (CAPA) processes - Provide hands-on coordination and investigation of failure investigations (FIR) from initiation to completion to ensure time-sensitive activities, documentation and approvals are completed - Ensure constant audit readiness for product line and assist in audit preparation and coordination to deliver successful audit results - Work and communicate 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 - Support prioritized activities, including NCR, CAPA, FIR and operational improvements - Help manufacturing with daily issues related to quality system requirements - Train and educate others on quality-system requirements and good documentation practices to help ensure compliance - Participate in and perform quality system compliance audits - Enhance quality systems (including software implementation and validation)
  • About the company

      W L Gore & Associates, Inc. is an American multinational manufacturing company specializing in products derived from fluoropolymers.

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