Supplier Quality Assurance Engineer

1 week ago

Santa Clara, California, United States Abbott Laboratories Full time
About the Role

Abbott Laboratories is seeking a highly skilled Supplier Quality Engineer to join our team in Santa Clara, CA. As a key member of our Structural Heart Business, you will play a critical role in ensuring the quality of our suppliers and their products.

Key Responsibilities
  • Provide guidance and training to Purchasing, R&D, Manufacturing, and Quality engineers on supplier selection, evaluation, and qualification.
  • Perform regular supplier assessments and re-evaluations to ensure compliance with Abbott and regulatory requirements.
  • Identify and solicit required documents from suppliers, track responses, and conduct follow-up and escalation as necessary.
  • Review and approve supplier quality agreements, product drawings, and component quality plans.
  • Manage the development of supplied product inspection procedures and first article requirements.
  • Provide engineering guidance to Abbott Receiving Inspection, including statistical analysis, measurement techniques, Gage R&R studies, and inspection procedures.
  • Assess supplier capabilities through direct visits, technical discussions, directed testing, and quality system audits.
  • Proactively communicate quality issues to suppliers through supplier quality system audits, supplier corrective action requests, and technical discussions.
  • Participate in and lead teams to support Supplier Development Quality program requirements.
  • Mitigate risk by working with suppliers to document Process Flow Charts, PFMEAs, and Control Plans.
  • Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
  • Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Requirements
  • Bachelor's degree in an Engineering field or related science-based discipline.
  • 2-4+ years of related work experience.
  • Solid verbal, written, and interpersonal skills with 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.
About Abbott Laboratories

Abbott Laboratories 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.

We offer a comprehensive benefits package, including career development opportunities, free medical coverage, an excellent retirement savings plan, tuition reimbursement, and a company recognized as a great place to work in dozens of countries worldwide.

Join our team and be part of 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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