The Supplier Quality Engineer will join our Quality Assurance Team who will be responsible for leading quality aspects of the Supplier Management process by providing engineering guidance and project leadership to the review, analysis and resolution of supplier quality issues.
Primary Duties and Responsibilities:
Work closely with the Engineering, Purchasing and Supplier Engineering groups to identify and qualify new suppliers.
Plan and lead audits for existing and proposed vendors.
Participate in the process of defining strategic suppliers.
Organize, trend and present supplier quality data and metrics to management.
Provide performance feedback to key/strategic suppliers.
Lead the MRB process and drive component non-conformance dispositions.
Review and approve sampling plans and inspection criteria for incoming parts and materials.
Initiate Supplier Corrective Actions and works with suppliers to investigate and resolve issues.
Qualify vendors for source inspection and/or Dock-to-stock programs.
Skills/Requirements
Requirements & Skills:
BS degree in Engineering discipline.
5 years experience in medical device, aerospace or automotive industry in the areas of quality systems, operations or supplier quality, with minimum of 2 years in Supplier Quality.
Certified Quality Auditor (CQA) certificate and/or Certified Quality Engineer (CQE) certificate is a plus.
Knowledge and application of QSR/GMP/ISO regulations related to manufacture of medical devices.
Strong analytical and statistical skills.
Six sigma training /certification is a plus.
Knowledgeable in various manufacturing methods: extrusion, injection molding, machining, PCBs.
Familiarity with quality improvement tools, including statistical methods (SPC, Cpk, etc).
Solid experience in root cause analysis methods and corrective/preventive actions (CAPA).
ABIOMED is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Veteran/Disabled.
