Supplier Quality Assurance Engineer

5 days ago

Santa Clara, California, United States Abbott Full time
About Abbott

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 Mission

Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease.

Job Summary

We are seeking a Supplier Quality Engineer to provide expertise in supplier selection, evaluation, re-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 that meet Abbott and regulatory requirements.

Key Responsibilities
  • Provides guidance and training to Purchasing, R&D, Manufacturing, and Quality engineers in applying program requirements.
  • Performs re-assessment of suppliers each year per a defined schedule.
  • Identifies supplier contacts and solicits required documents from suppliers.
  • Tracks supplier responses and conducts follow-up and escalation as necessary.
  • Conducts phone calls with suppliers as needed to expedite responses or answer questions.
  • Reviews current Quality Agreements and determines the need to revise.
  • Solicits revised Quality Agreements as determined.
  • Obtains and analyzes performance and quality indications information from internal sources for each supplier.
  • Prepares and submits required quality records and documents for closure and filing.
  • Reviews and approves all supplied product drawings and component quality plans.
  • Manages the development of supplied product 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 judgment to reduce the need for inspection in accordance with program policies.
  • Works with Manufacturing engineering to assess and address purchased product issues.
  • Participates in or leads teams in supporting Supplier Development Quality program requirements.
  • Mitigates risk by working with 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.
  • Contributes to the development, maintenance, and improvement of Abbott supplier development quality program policies, procedures, and forms.
Requirements
  • Bachelor's degree within an Engineering field or related science-based discipline.
  • 2-4+ years of related work experience.
  • Solid verbal, written, and interpersonal skills with the ability to effectively communicate at multiple levels in the organization.
  • 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.
  • Multitasks, prioritizes, and meets deadlines in a timely manner.
  • Strong organizational and follow-up skills, as well as attention to detail.

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