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Sr. Quality Engineer - Supplier Quality
200 W. Mercer Street Seattle, WA 98119 US
Job Description
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.
Meet Your Recruiter
Abby Hubbard
I joined Protingent in the Spring of 2021 as a sales intern, transitioning to a full-time Technical Recruiter after graduating from the University of Washington in June 2021. Initially, I focused on supporting our spaceflight clients, later expanding to industries such as sustainable energy and nuclear power. While I’ve broadened my recruiting scope, I’m still partial to aerospace engineering, especially anything related to propulsion technology.
My recruiting style focuses on individual candidate needs and relationship building. My philosophy is to lead with empathy and integrity. My favorite thing about recruiting is the opportunity to learn something new every day by talking to the most intelligent people/engineers, as well as the potential to impact critical industries at the staffing level.
When I’m not recruiting, I love spending time outdoors – hiking, camping, roller skating, reading in parks, and swimming in Lake Union (when the Seattle weather permits). I also enjoy thrift shops, sewing/up-cycling clothes, and shooting 35mm film.