Job Description

About the Role: We are looking for a Systems Quality Assurance Associate to join our Model Based Systems Engineering Project team which is focused on delivering systems and tools that will increase the speed of medical product innovation in alignment with our Medical Product Division\xe2\x80\x99s (MPD) digital transformation initiatives. In this role, you will partner with a cross-functional team to support the development or revision of Requirements Management, Risk Management, and Verification and Validation processes and workflows as they are created and/or transitioned to new systems. You will ensure implemented solutions are developed in accordance with and meet applicable regulations and standards, MPD Quality System requirements, and project objectives with a focus on providing solutions that support a sustainable, scalable, and simplified quality system.

This is a remote position, and you can work from home in most locations within the United States.

Responsibilities:

• Partner with cross functional system implementation teams to ensure integration and alignment with business objectives for targeted processes
• Support planning and execution activities for the transition of quality processes, through partnership with MPD and Enterprise cross functional System Implementation teams
• Provide Quality Assurance (QA) support to Associates authoring or revising procedures, quality plans, etc. to facilitate the development, transfer, and sustainment of workflows into new systems
• Support the documentation of quality system specific user requirements and ensure these requirements are met
• Partner with appropriate functions/Associates in mentoring teams, influencing data migration strategy, re-writing and validating procedures, and documenting the execution of this work in the quality system
• Partner with Training Associates to develop, deliver, and document training
• Provide feedback on the usability and functionality of new processes and systems
• Be agile, flexible, and open to making unique or unconventional changes while ensuring QS compliance; be comfortable handling risk and uncertainty based on a well vetted and appropriate assessment
• Maintain compliance with training expectations as required for this position
• Perform additional responsibilities as required within the scope of position

Required Qualifications:

• Minimum 3 years experience working in a Quality Assurance (QA), Engineering or Manufacturing operations role in medical-device, pharmaceutical, biotech
• Previous experience implementing or validating software applications (ERP, EQMS, PLM, MES or EAM
• Demonstrated history of partnering and influencing teams cross-functionally
• Excellent written and oral communication and presentation skills
• Ability to self-direct and work independently
• Ability to identify and prioritize tasks to help drive projects to completion

Desired Qualifications:

• Previous experience working on Divisional or Enterprise projects

Remote Working Arrangements are permitted for Associates in the continental United States (US) and Canada, with appropriate approval and compliance with Gore\xe2\x80\x99s remote working policies, from the country in which they are employed. \xe2\x80\x8bFor fully remote roles, the following locations are not eligible for new fully remote work arrangements: Alaska and Hawaii (for all roles), and Rhode Island (for wage/hourly roles only). \xe2\x80\x8b

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 \xe2\x80\x9cprofit-sharing\xe2\x80\x9d. 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

Additional Information

• Travel%: 10%
• Shift: Day Job
• Schedule: Full-time
• Posting Date: Sep 20, 2023

About Gore

For 65 years, Gore has improved lives through discovery, product innovation and rewarding careers for Associates. We push the boundaries of what\'s possible - not just through our products and technologies but also through individual growth and development.

W. L. Gore & Associates