Senior Supplier Development Quality Engineer

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 114,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.

• Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical plan in the next calendar year.

• An excellent retirement savings plan with a high employer contribution

• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.

• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Pleasanton, CA location in the Heart Failure Division. In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives.

We are seeking an experienced, high caliber Senior Supplier Development Quality Engineer to be responsible to act as the site interface to suppliers.

What You’ll Work On

• Drives the development, maintenance and improvement of quality of components sourced from outside suppliers.

• Reviews new design 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.

• 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 and technical discussions.

• Leads the investigation, resolution and prevention of supplied component nonconformances.

• Contributes and participates in supplier performance reviews.

• 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.

• Works with Manufacturing Engineering to assess and address supplied component issues.

• Applies systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

• Designs and conducts experiments for design and process optimization and/or improvement.

• Appropriately document experiment plans and results, including protocol writing and reports.

• Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)

• 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.

Required Qualifications

• BS degree in Engineering or Technical Field or equivalent experience

• 5+ years related work experience

• Engineering experience and demonstrated use of Quality tools/methodologies

• Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971

• 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

Preferred Qualifications

• 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 experience preferred

• Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)

Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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The base pay for this position is

$86,700.00 – $173,300.00

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Operations Quality

DIVISION:

HF Heart Failure

LOCATION:

United States > Pleasanton : 5000 Franklin Dr

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 10 % 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), Keyboard use (greater or equal to 50% of the workday)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: is the Law link - Espanol: #J-18808-Ljbffr