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Sr. Quality Engineer - Supplier Quality

Seattle, WA 98119

Posted: 05/31/2023 Employment Type: Direct Hire Industry: Core Technologies - FTE Job Number: 27399

Job Description

Position Title: Sr. Quality Engineer - Supplier Quality 

Position Description: Protingent Staffing has an exciting Direct Hire opportunity with our client in Seattle, Washington for an experienced Sr. Quality Engineer - Supplier Quality. 

Job Responsibilities:
  • Manage all aspects of the Supplier Quality program. Collaborate with Suppliers to assure ongoing QMS compliance.
  • Process customer complaints in accordance with the quality procedures.
  • Evaluate regulatory reportability, communicate with company stakeholders, support investigations, and present monthly metrics. Escalate issues to the leadership team.
  • Support cross-functional engineering teams with activities such as design change analysis and design requirements, and ensure compliance with applicable processes and regulations.
  • Participate in risk management activities in accordance with ISO 14971 (Risk Management Plan, Hazard Analysis, FMEAs, RM Report).
  • Develop policies and procedures to continuously improve the Quality Management System.
  • Participate in internal and external audits and regulatory inspections.
  • Review quality records and documentation.
Job Qualifications:
  • Five (5) to eight (8) years of experience in a medical device manufacturing environment, or other regulated industries
  • Bachelor’s degree in Engineering or related science field
  • Quality Management System and Document Management Experience
  • Expertise with 21 CFR 820, ISO 13485, ISO 14971 and EU MDR and CE regulatory requirements
  • Strong experience with Supplier qualification, customer complaints, and Risk Management
  • Experience with process and equipment validations
  • Strong in Microsoft Office and statistical analysis software
  • Strong technical writing skills
Job Details:
  • Direct Hire
  • Salary Range: $115 – 140k/year

About Protingent: Protingent is a niche provider of top Engineering and IT talent to Software, Electronics, Medical Device, Telecom, and Aerospace companies nationwide. Protingent exists to make a positive impact and contribution to the lives of others as well as our community by providing relevant, rewarding, and exciting work opportunities for our candidates.

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Abby Hubbard

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