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Sr. Supplier Quality Engineer

Apply Now Job ID R-333913 Date posted 03/25/2019

Job Description Summary

Job Description

Job Description


1.    Perform on-site audits of new and existing suppliers using standards ISO 13485:2016, ISO 9001, ISO 17025
2.    Provide technical support to resolve quality problems with suppliers
3.    Assist with dispositioning of rejected non-conforming products (MRB)
4.    Issue and manage Supplier Corrective Action Requests (SCARs)
5.    Support supplier Component Qualification activity as needed.

Essential Duties and Position Responsibilities

  • Perform on-site audits of new and existing suppliers using standard ISO 13485, 9001 and 17025 checklists.
  • Plan and develop the Quality Control Program for various projects often within the context of a franchise project team.
  • Perform qualification studies for new suppliers or equipment by managing GR&Rs, FAIs, Capability Studies and Control plans.
  • Provide technical support to resolve quality problems in Operations or with suppliers as warranted.
  • Design and conduct Quality Engineering studies to determine causes of supplier quality non-conformances, initiate changes in process, tooling, product design, etc. to correct them.
  • Assist with the dispositioning of rejected nonconforming products; conduct MRB action when required.  Assure segregation and identification of rejected material and implementation of disposition by Production Personnel.
  • Assist with the managing of the weekly Materials Review Board (MRB) to include proper documentation.
  • Issue and manage Supplier Corrective Action Responses (SCAR) including the maintenance of the SCAR Tracking Log.
  • Organize and generate detailed quality information reports to Quality, Engineering, Operations, and Management.
  • Plan and coordinate quality activities which involve Production, Planning, Inventory & Control, Engineering, etc.
  • Support supplier Component Qualification activity as needed.
  • Conduct internal Quality System audits per schedule.
  • Support the goals of the Quality Assurance Department and Profit Improvement Projects.  Contribute ideas to these programs and work on implementation.  Serve on committees, teams, task forces as assigned.
  • Conduct other Quality Control Projects as assigned by the managers of Supplier Quality Engineering and Quality Systems.
  • Exercise control over the quality of conformance of the products generated in areas assigned.

Basic Qualifications

  • Bachelor's Degree with 4+ years of relevant Quality work experience.
  • Minimum of  2 to 5 years experience in a supplier quality/supplier auditing capacity or equivalent preferred or equivalent quality function. 

Additional Qualifications

  • Experience in internal Quality System auditing (preferred).
  • Wide range of experience in different businesses:  Medical Devices, Combination Devices, Pharmaceutical/API/Polymers, Calibration, Test Laboratories, Human/Animal Grafts, Injection Molding, and Packaging/Labeling (preferred)
  • Demonstrated ability to apply statistical quality engineering tools in a supplier environment. 
  • Preferred working knowledge of medical device manufacturing systems, ISO 13485 and FDA regulations.
  • A high level of competence in Quality Technology including statistical techniques, control charts, sampling plans, Quality costs, design of experiments, correlation and regression, analysis of variance, probability, etc.  Experience with statistical packages; preference to Minitab
  • Certified Quality Engineer and/or Certified Quality Auditor certificates from American Society for Quality Control.
  • Conduct unassisted 1-3 day Supplier Quality System/Process Audits; ~40% of time devoted to local, US and international travel requirements.
  • Certified Six Sigma Green Belt or Black Belt (preferred)
  • Good oral and written communication skills.
  • Ability to work with and motivate people.


Primary Work Location

USA RI - Warwick

Additional Locations

Work Shift

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