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Protingent
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Sr. Quality Engineer - Supplier Quality
200 W. Mercer Street Seattle, WA 98119 US
Posted: 05/31/2023
2023-05-31
2023-11-02
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:
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.
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.
- 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
- 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.