Senior Manufacturing Quality Engineer

WL Gore Medical Products Division   •  

Phoenix, AZ

Industry: Pharmaceuticals & Biotech

  •  

8 - 10 years

Posted 43 days ago

About Us: Gore is a materials science company focused on improving lives through discovery, product innovation and rewarding careers for our Associates. Learn More.

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.

About the Role: Quality Engineers are responsible for ensuring fitness for use of product designs by assessing the design’s capability to meet specification and satisfy customer needs. In this role, you will be a valued member of a cross functional product manufacturing support team in the Medical Products Division (MPD) who is responsible for supporting product being manufactured and delivered to our customers. You will be expected to gain deep knowledge of the product manufacturing, documentation/history and apply understandings to the current product landscape and manufacturing needs. You will support continuous improvement, regulatory compliance initiatives, evaluation of risk, and implement material, design, and test changes. Upon joining the team, you will also have the opportunity to mentor others, build a diverse, equitable and inclusive environment, and be a part of a winning manufacturing team which delivers lifesaving products into the hands of our customers.

Responsibilities:

  • Developing deep technical and historical knowledge of the product/product documentation and applying it to decision making and/or product reviews
  • Ensuring continued compliance ISO and other global quality standards/ guidelines for product design and performance. Performing periodic reviews and addressing gaps as standards revise
  • Ensuring compliance with design control requirements. Planning verification, validation, and usability testing of changes to commercial designs
  • Supporting post-market surveillance of commercial products by participating in cross-functional assessments and performing engineering evaluations of returned devices
  • Leading cross-functional root cause investigations. Reviewing customer, manufacturing, and test data against established risk documentation to recommend design updates or other changes
  • Leading evaluation of impact of supplier changes
  • Maintaining product line technical documentation (Design History File including: design Input / Output documentation and product risk management tools (i.e. Hazard Analysis, FMEAs))
  • Maintaining a working knowledge of all product test methods
  • Driving and providing support to quality processes (non-conformance, CAPA, change management, field events, audits, etc.
  • Mentoring and driving best practices to develop functional excellence of early career engineers. Provide consultation, coaching and guidance on project work and change evaluations.

Required Qualifications:

    • Bachelor's degree in science or engineering
    • Minimum of 7 years' experience as a product test/development engineer
    • Experience in test method development and specification development
    • Demonstrated ability to prioritize, initiate, and drive projects to completion
    • Demonstrated excellent written and oral communication and presentation skills
    • Knowledge of Design Control activities and best practices
    • Solid knowledge of engineering and statistics fundamentals and ability to apply this knowledge to manufacturing and product design
    • A work style of hands-on involvement with all phases of projects
    • Ability to network and interact effectively with a broad range of associates internally as well as external suppliers spanning various disciplines and responsibilities

Desired Job Qualifications:

  • ASQ Certified
  • Lean/Six Sigma Certification
  • Design Assurance / Medical device experience

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 about: benefits,diversity, and growth & development.

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.)

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