New Product Development Quality Assurance Associate Job at W. L. Gore & Associates

W. L. Gore & Associates Phoenix, AZ

Job

: Supply Chain

Primary Location

: Americas-US-AZ-Phoenix

Other Locations

: Americas-US-MD-Elkton, Americas-US-AZ-Flagstaff
Travel% : 10%

Shift

: Day

Schedule

: Full-time

New Product Development Quality Assurance Associate - 230160

About 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.*

Responsibilities:
  • 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.

Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening.
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.
Gore is a M/F, Disabled and Vet EEO/AA employer. (Applies to all positions in the U.S.)
Our Talent Acquisition Team welcomes your questions at gore.com/careers/contact




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