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Protingent
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Sr. Quality Engineer
200 W. Mercer Street Seattle, WA 98119 US
Posted: 03/09/2023
2023-03-09
2023-04-24
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:
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 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.
- 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
- 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.