Supplier Development Quality Engineer II (Berkeley)

Abbott in Berkeley, CA

  • Industry: Engineering - Industrial Engineer
  • Type: Full Time
  • $106,650.00 - 158,660.00
position filled
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 Engineer II Supplier Development Quality Engineer. Supplier Development Quality Engineers are responsible for activities related to supplier selection and evaluation, material qualification, supplier performance and receiving inspection.This position contributes to the development, establishment and maintenance of supplier quality engineering methodologies, systems and practices which meet Abbott and regulatory requirements.

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 actions and accomplish goals.

Impact this role will have on Abbott:

Contributes to the development, maintenance and improvement of Abbott supplier development quality program policies, procedures and forms

Provides guidance and training to Purchasing, R&D, Manufacturing and Quality engineers in applying program requirements

Reviews and approves all supplied product drawings and component quality plans

Manages development of supplied product/component qualification plans, including supplier validations, control plans, inspection procedures, and first article requirements

Provides engineering guidance to Abbott Receiving Inspection including statistical analysis, measurement techniques, Gage R&R studies and inspection procedures

Assesses supplier capabilities through direct visits, technical discussions, directed testing and quality system audits

Proactively communicates quality issues to suppliers as needed through supplier quality system audits, supplier corrective action requests and technical discussions

Participates and provides engineering ownership for all supplied product Non-Conforming Material Reviews

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 sound engineering analysis and judgement to reduce the need for inspection in accordance to program policies

Works with Manufacturing engineering to assess and address purchased product issues

Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues

Design and conduct experiments for process optimization and/or improvement

Participate in or lead teams in supporting Supplier Development Quality program requirements (e.g., represent the Supplier Development Quality function as a Core Team Member)

Mitigates risk by working 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

3-7 years Medical Device and/or Engineering experience

Ability to work in a highly matrixed and geographically diverse business 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

Your preferred qualifications and education:

Advanced degree preferred

Engineering experience and demonstrated use of Quality tools/methodologies

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

Strong 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

ASQ CQE or other certifications preferred

Associated topics: business, cost efficient, industrial engineer, manufacturing engineer, methods engineer, project, sap, supply, supply chain

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