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Prin Supplier Qual Engineer

Billerica, MA 01821

Posted: 06/01/2023 Employment Type: Contract Job Category: Engineering Job Number: 566049 Is job remote?: No Country: United States

Job Description


Support and lead QMS integration activities per company requirements.
  • Support and lead Product Qualification activities ensuring suppliers are capable of delivering quality products, materials, and services.
  • Assess and qualifies suppliers according to company requirements. 
  • Monitors products from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems before they occur.
  • Provides technical guidance and quality compliance for Supplier Quality engagement throughout the Product lifecycle.
  • Lead and develop the Product Acceptance Strategy for incoming inspection and associated test method validation for all internal company Test Methods.
  • Implement a Certified Supplier Program supporting Receiving Inspection to improve cost effectiveness.
  • Provide routine communication and updates to leadership regarding supplier activities and performance.

 

Top 3 things you are looking for in a candidates experience (please be specific):
  1. Medical Device Experience
  2.  Electrical background
  3.  Component / Product Qualification – Including Test Method Validations, Equipment / Process Validations, strong understanding of process capability.

Education Required: Bachelors (Electrical Engineering ) 

Years’ Experience Required: > 4 years

 

Must Have
  • Electrical Engineering Degree
  • PPAP
  • Process Validation, Change Management Processes, Statistical Analysis.
  • Product qualification
  • Risk Analysis
  • Test Method Validation

Nice To Have
  • Agile MAP Experience
  • CAPA
  • DOE
  • Incoming Inspection Methodologies
  • NCMRs
  • Supplier Audits
Knowledge and Experience: Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience. May have broad knowledge of project management. Requires a University Degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.
 
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