New Product Development Quality Assurance Associate Job at W. L. Gore & Associates
Job
: Supply ChainPrimary Location
: Americas-US-AZ-PhoenixOther Locations
: Americas-US-MD-Elkton, Americas-US-AZ-FlagstaffShift
: DaySchedule
: Full-timeAbout Us: Gore is a materials science company focused on improving lives through discovery, product innovation and rewarding careers for our Associates.
About the Industry: Saving lives and improving the quality of life for patients is at the core of everything we do. This meaningful work gives purpose to our lives and inspires us to create solutions that make a difference in the lives of others. Learn more at gore.com/products/industries
About the Role: We are looking for a New Product Development (NPD) Quality Assurance Associate to join the Medical Products Division (MPD) NPD QA team who will provide support to our NPD teams in the execution of Design Control and working effectively in the Quality System.
This position offers multiple work arrangements: on-site at one of our facilities in Phoenix or Flagstaff, Arizona or Elkton, Maryland, hybrid or fully remote work allowed in most locations within the United States, depending upon the responsibilities of the role and business needs.*
- Directly support New Product Development of innovative products
- Provide subject matter expertise in the design control process
- Review design control and supporting documentation and coach team members on quality system execution
- Perform compliance audits and interface with external manufacturers and/or suppliers
- Develop procedures and initiate change documentation in support of new and existing products
- Support day to day manufacturing processes and problem solve, CAPA and nonconformance investigations and respond with appropriate risk based decision making
- Collaborate with and influence cross functional teams (e.g., technical, operations, regulatory, document control, maintenance and calibration, environmental monitoring and control)
- Develop quality reports to support assessments of quality-system effectiveness
Required Qualifications:
- Minimum 3 years experience in Quality Assurance and/or Quality Engineering in the medical device, pharmaceutical, or life science industries
- Demonstrated knowledge of FDA quality system regulations and ISO standards (e.g. 21 CFR 820, ISO 13485)
- Excellent written and oral communication skills
- Demonstrated strong interpersonal skills
- Proven conflict resolution skills
- Demonstrated ability to work independently, as well as part of a diverse team
- Demonstrated ability to prioritize work and meet aggressive timelines
- Ability to travel up to 10%
Desired Qualifications:
- Bachelor's degree in Engineering or Science
- Experience supporting new product development in the medical device, pharmaceutical, or life sciences industries; experience working with endovascular and catheter-based technologies
- Experience integrating outsourced manufacturing into the design control process and experience designing or developing Quality System procedures
*Remote Working Arrangements are permitted for Associates in the continental United States (US) and Canada, with appropriate approval and compliance with Gore’s remote working policies, from the country in which they are employed. Locations not eligible for new remote work arrangements include: Alaska and Hawaii (for all roles), and Rhode Island (for wage/hourly roles only).
What We Offer: At Gore, we offer comprehensive, competitive rewards in the form of compensation and benefits. Among these are work-life balance and sports programs, 401(k) Plan with a gift, Associate Stock Ownership Plan, health & well-being program with full health plan, and a flexible working program. Within Gore, you will find a unique culture, diversity, equity, and inclusion initiatives, and opportunities for growth and development. Learn more at gore.com/careers
We believe in the strength of a diverse workforce and inclusive work environment. In support of our values and continued success we are proud of Associates around the world who support an inclusive work environment, strive to reflect the diversity of the communities where we operate, and ensure all Associates and external partners are treated with fairness, dignity and respect.
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