Medical Device Quality Assurance
2 days ago
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 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.
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