1+ months

Senior Supplier Quality Engineer

Abbott
Santa Clara, CA 95050

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.  We aim to lead the markets we serve by requiring the solutions we offer customers provide an improved benefit/risk profile as compared to existing standards of care; a performance threshold that by definition, guides and ensures the productive output of our engineering, business development, and clinical research efforts result in outcomes that advance the standard of care.

WHAT YOU’LL DO 

We are seeking an experienced, high caliber Senior Supplier Development Quality Engineer to be responsible to act as the site interface to suppliers. Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.

  • Drives the development, maintenance and improvement of quality of implantable heart valve components sourced from outside suppliers.
  • Reviews new heart valve components specifications and proposes changes to existing specifications to support component quality and manufacturability.
  • Develops all supplied component quality plans to drive component qualification throughout the lifecycle of the design.
  • Manages development of supplied product inspection procedures and first article requirements.
  • Responsible for Supplier Quality activities such as: Supplier Audits, Supplier performance, etc.
  • Provides engineering guidance to Abbott Receiving Inspection including statistical analysis, measurement techniques, and Gage R&R studies.
  • Assesses supplier capabilities through direct visits, technical discussions, and directed testing.
  • Collaborates with suppliers to develop comprehensive process validation strategies.
  • Proactively communicates quality issues to suppliers as needed through supplier corrective action requests, data driven and technical discussions.
  • Leads the investigation, permanent resolution and prevention of supplied component nonconformances.
  • Responsible for Supplier Performance and Evaluation.
  • Evaluates and develops Supplied Data Agreement, Skip Lot, Dock-to-Stock, CoC, and CoA partnerships with suppliers.
  • Applies thorough engineering analysis and judgement to reduce the need for inspection in accordance to program policies and data gathered.
  • Works with Manufacturing Engineering to assess and address supplied component issues.
  • Applies systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Participate in or lead teams in supporting Supplier Quality program requirements (e.g., represent the Supplier Quality function as a Core Team Member).
  • Mitigates risk by work in partnership with the suppliers to document Process Flow Charts, PFMEAs, and Control Plans.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Performs other related duties and responsibilities, on occasion, as assigned.

EDUCATION AND EXPERIENCE YOU’LL BRING 

Required 

  • BS degree in Engineering or Technical Field or equivalent experience; advanced degree preferred
  • 5+ years’ Engineering experience and demonstrated use of Quality tools/methodologies
  • Detailed knowledge of FDA, GMP, ISO 13485, ISO 14971, and ISO 22442
  • Solid communication and interpersonal skills
  • Advanced computer skills, including statistical/data analysis and report writing skills
  • Ability to work in a highly matrixed and geographically diverse business environment
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment
  • Ability to leverage and/or engage others to accomplish projects
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
  • Multitasks, prioritizes and meets deadlines in timely manner
  • Strong organizational and follow-up skills, as well as attention to detail
  • Ability to travel approximately 10%
  • Ability to maintain regular and predictable attendance

Preferred 

  • Training and/or Certification to ISO 22442
  • Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner
  • Prior medical device (implantable) manufacturing experience preferred but not necessary.
  • Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)

WHAT WE OFFER  

At Abbott, you can have a good job that can grow into a great career. We offer: 

  • A fast-paced work environment where your safety is our priority
  • Production areas that are clean, well-lit and temperature-controlled
  • Training and career development, with onboarding programs for new employees and tuition assistance  
  • Financial security through competitive compensation, incentives and retirement plans  
  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs 
  • Paid time off  
  • 401(k) retirement savings with a generous company match 
  • The stability of a company with a record of strong financial performance and history of being actively involved in local communities 

Learn more about our benefits that add real value to your life to help you live fully:  www.abbottbenefits.com  

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity. 

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal. 

","industry":"Healthcare","title":"Senior Supplier Quality EngineerDivision: SH Structural Heart
Additional Location: United States - Minnesota - St. Paul
Travel: Yes, 25 % of the Time
Medical Surveillance: Not Applicable
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Categories

Posted: 2021-02-17 Expires: 2021-05-09

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Senior Supplier Quality Engineer

Abbott
Santa Clara, CA 95050

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