Regulated Quality Assurance Professional

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