Abbott Senior Supplier Development Quality Engineer in Pleasanton, California
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 103,000 colleagues serve people in more than 160 countries.
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 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.
BS degree in Engineering or Technical Field or equivalent experience; advanced degree preferred
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
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
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
5+ years’ experience
Prior medical device experience preferred but not necessary.
Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org