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Protingent
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Position Title: Senior Quality Engineer
Position Description: Protingent Staffing has an exciting contract opportunity with our client in Redmond, Washington for an experienced Senior Quality Engineer
Job Responsibilities:
Job Qualifications:
Job Details:
Benefits Package: Protingent offers competitive salaries, insurance plan options (HDHP plan or POS plan), education/certification reimbursement, pre-tax commuter benefits, Paid Time Off (PTO), and an administered 401k plan.
About Protingent: Protingent is a niche provider of top Engineering and IT talent to product development 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.
Senior Quality Engineer
8201 164th Ave NE , Suite 330 Redmond, WA 98052 US
Posted: 04/15/2025
2025-04-15
2025-05-22
Employment Type:
Contract
Department: Core Technologies - Contract
Job Number: 30387
Industry: MDEV - Medical Device
Job Description
Position Title: Senior Quality Engineer
Position Description: Protingent Staffing has an exciting contract opportunity with our client in Redmond, Washington for an experienced Senior Quality Engineer
Job Responsibilities:
- Provide quality input for all phases of product development, including support for design inputs, verification, validation, and design transfer.
- Ensure compliance with design control requirements per 21 CFR Part 820 and ISO 13485.
- Maintain and update risk management documentation in accordance with ISO 14971.
- Translate user needs into measurable requirements and support traceability through the product lifecycle.
- Review and approve design documentation, including protocols, reports, specifications, engineering change orders.
- Support compliance with applicable standards, including IEC 60601, ISO 14708, IEC 62304 (software), and IEC 62366-1 (usability).
- Stay current with industry trends and updates to ensure compliance with evolving standards and technologies.
- Support internal and external audits, and regulatory submissions and inspections.
Job Qualifications:
- Bachelor's degree in Engineering, Life Sciences, or a related field; advanced degree preferred.
- 5+ years of experience in medical device quality engineering, with a focus on Class III or implantable devices.
- Deep knowledge and hands-on experience with:
- Product Development & Design Controls
- FDA Quality System Regulation (21 CFR Part 820) & ISO 13485
- Risk Management (ISO 14971)
- IEC 60601 & ISO 14708 standards
- Design Input and Requirements Development
- Design Verification & Design Validation
- Software Development Lifecycle per IEC 62304
- Corrective and Preventive Actions (CAPA) & Product Investigations
- Usability Engineering per IEC 62366-1
- Strong cross-functional communication and documentation skills
- Ability to work independently in a fast-paced, highly collaborative environment.
Job Details:
- Job Type: Contract
- Location: Redmond, WA.
- Pay rate range: $65-85/hr.
Benefits Package: Protingent offers competitive salaries, insurance plan options (HDHP plan or POS plan), education/certification reimbursement, pre-tax commuter benefits, Paid Time Off (PTO), and an administered 401k plan.
About Protingent: Protingent is a niche provider of top Engineering and IT talent to product development 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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Discover exciting job opportunities in the vibrant Redmond, Washington area! Nestled in the scenic Pacific Northwest, Redmond offers job seekers a unique blend of tech innovation, outdoor recreation, and cultural charm. Known as the "Bicycle Capital of the Northwest," Redmond boasts an extensive network of bike trails perfect for exploring the stunning Cascade Mountains. With nearby attractions like the iconic Space Needle in Seattle, the picturesque wineries in Woodinville, and the world-renowned Museum of Glass in Tacoma, there's no shortage of adventures to be had. Whether you're drawn to the bustling tech scene with companies like Microsoft and Nintendo, or craving a taste of the local cuisine at the Food Truck Roundup, Redmond has something for everyone. Join us in experiencing the dynamic opportunities and endless possibilities that await in this thriving region!