Quality Engineer

Company: W.L. Gore & Associates
Location: Santa Clara
Posted on: April 15, 2024

Job Description:

About the Role: We are looking for Quality Engineer to join our Medical Products Division. As a Quality Engineer you can contribute to product lifecycle areas, which may include Manufacturing, New product transfer, or Technology Platform.

This position will be located at our facility in Sunnyvale, California, with the possibility of a hybrid remote work arrangement, depending upon the responsibilities of the role and business needs.

Pay and Benefits:

• $ 109,000 - $137,000 per year
• Factors considered in extending an offer within this pay range include (but not limited to) education, experience, knowledge, skills, and abilities.
• Medical, Dental and Vision benefits effective on Day 1 of employment! We offer a comprehensive total rewards package, including competitive benefits. More details are available at www.gore.com/careers/benefits
  
  Responsibilities:
  • Develop deep technical and historical knowledge of the product/product documentation to support quality processes (audit, change control, complaint evaluations) and drive the discovery of root causes in non-conformance and CAPAs
  • Ensure continued compliance to ISO and other global quality standards/ guidelines for product design and performance; address documentation gaps and updates (i.e. FMEA,ERT, PERC etc)
  • Document and communicate technical plans, experimental results, and conclusions of work to satisfy quality system requirements and enable future use of knowledge
  • Ensure design requirements are met: own quality engineering design control deliverables and maintain product Design History Files (i.e. Design input/output documentation, Risk management tools)
  • Provide support and mentorship: utilize engineering principles and historical/materials/clinical/mechanical knowledge to ensure quality decisions are made related to product release, and supplier quality
  • Maintain working knowledge of all implemented test methods, necessary test method validations, and validated test equipment, which are internally aligned and externally benchmarked
  • Employ statistical techniques to promote data driven decisions to establish sampling plans/troubleshoot/drive continuous improvement
    
    Required Qualifications:
    
    • Bachelor's Degree in Engineering and a minimum 3 years of hands-on engineering work experience
    • Experience applying structured problem-solving approach (such as 8D, 8-Step, DMAIC or PDCA) that drives root cause analysis using 5-Why, Why Trees, and Fishbone analysis
    • Knowledge in product risk management (risk identification, analysis, and mitigation methods)
    • Ability to prioritize, plan, and drive multiple projects concurrently from development to completion against agreed upon timelines and deliverables
    • Ability to apply engineering fundamentals and statistical analysis to product quality support, trending, improvement, and troubleshooting
    • Ability to work effectively in team situations, building an inclusive environment, mentoring others as well as the ability to independently prioritize, initiate and drive projects to completion
    • Ability to document, communicate, and present technical bodies of work
    • Ability to travel up to 5%
      
      Desired Qualifications:
      
      • Experience in a Regulated Industry
      • Experience coaching or mentoring
      • Experience with quality systems, documentation, and methodologies (for example, GMP, ISO 9001, APQP, House of Quality, etc)
        
        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
        
        #LI-MSL

Keywords: W.L. Gore & Associates, San Francisco , Quality Engineer, Engineering , Santa Clara, California