Job Description

Job Description

About the Role: We are looking for a Regulated Quality Assurance Associate to join the Gore Medical Components (GMC) 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 for GMC.

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

Responsibilities: \n

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• Translate quality standards and customer requirements into productive procedures, practices, and behaviors

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• Give guidance, interpretation, and assistance in application of quality system procedures and practices

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• 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

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• Drive improvements to increase the effectiveness of quality processes and controls

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• Review and approve quality related documents (corrective actions, non-conformances, changes, etc.)

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• Write defensible rationales that follow good technical writing practices (background, supporting evidence, broader justification and a decisive conclusion)

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• Utilize project management best practices to plan, execute, and close projects while actively seeking diverse perspectives as inputs

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• Create detailed project plans to provide clear timelines and expectations

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• Serve as a change agent: promote, champion, enable, and support changes made in the organization
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Required Qualifications:

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

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• ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE)

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• Experience participating in quality audits as an audit team member, or in support of customer/external audits

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• Experience applying tools such as Failure Mode Effects Analysis (FMEA), Fault Tree Analysis (FTA), Hazard Analysis and Critical Control Points (HACCP), Hazard Operability Analysis (HAZOP), Preliminary Hazard Analysis (PHA), or risk ranking and filtering 

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• An understanding of the application of statistical tools and techniques which could include: statistical process control, design of experiments, confidence claims and sampling plans, measurement systems analysis, and gauge R&R
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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

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