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Sr Supplier Qual Engineer

Billerica, MA 01821

Posted: 06/01/2023 Employment Type: Contract Job Category: Engineering Job Number: 567070 Is job remote?: No Country: United States

Job Description

In this exciting role as a Senior Supplier Quality Engineer you will have the opportunity to work with new acquisitions across the company. 

This key role will support supplier quality engineering activities including QMS integration activities and ensuring product requirements are met while maintaining product quality, safety and compliance.  Our Global Quality Strategy is rooted in the company Mission and our Quality Policy. Being a 'trusted partner' means always putting patient safety first, upholding product quality, and maintaining the highest ethical standards in our business relationships and programs.


A Day in the Life:
  • 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 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 candidate’s experience (please be specific):
  1. Medical Device Experience
  2.  Mechanical background
  3.  Component / Product Qualification – Including Test Method Validations, Equipment / Process Validations, strong understanding of process capability.

Education Required: Bachelors: (Mechanical / Biomedical Engineering)

Years’ Experience Required: > 4 years

Must Have

  • Mechanical / Plastic Manufacturing
  • 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
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