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)