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Sr. Quality Engineer

Seattle, WA 98119

Posted: 03/09/2023 Employment Type: Direct Hire Industry: Core Technologies - FTE Job Number: 26962

Job Description

Position Title: Sr. Quality Engineer

Position Description: Protingent Staffing has an exciting Direct Hire Sr. Quality Engineer opportunity with our client in Seattle, Washington.
Job Responsibilities:
  • Lead as the Quality representative for the product transfer process, including design input, design V&V activities, design transfer and product realization, and performance in the field to ensure all design requirements are effectively met.
  • Support cross-functional engineering teams with activities such as design change analysis, design requirements, verification testing methods, protocols and reports and ensure compliance with applicable processes and regulations.
  • Drive risk management activities in accordance with ISO 14971 (Risk Management Plan, Hazard Analysis, FMEAs, RM Report).
  • Responsible for ensuring Design History File and Device Master File documentation is present, compliant, and maintained.
  • Develop policies and procedures to continuously improve the Quality Management System
  • 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
  • Demonstrated success working with international contract manufacturers
  • Skilled at managing projects in an engineering lead capacity. Inspire others and drives projects forward.
  • Demonstrated use of Project Management tools (preferred)
  • Expertise with 21 CFR 820, ISO 13485, ISO 14971 and EU MDR CE regulatory requirements
  • Proven experience with product transfer, Design Controls and Risk Management
  • Significant experience with mold, process, and equipment validation
  • Proficient process development skills using appropriate (e.g., Process Mapping, Flow Charts, SIPOC, SPC)
  • Strong in Microsoft Office and statistical analysis software
  • Exceptional 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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Britt Oswald

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