Quality Assurance Specialist
11911 North Creek Parkway South Bothell, Washington 98011 | Direct Hire
Position Title: Quality Assurance Specialist
Position Description: Our Bothell client is looking to bring on a Quality Assurance Specialist to perform quality engineering and quality system related tasks to support the design, development, and production of medical device systems.
• Perform investigation on products/data returned for product complaints and write investigation reports.
• Administer and maintain the Non-Conformance Report system.
• Administer and maintain the Calibration system.
• Assist with Corrective Action and Preventative Action (CAPA) investigations and reporting.
• Support Document Control to comply with Client' s Quality System and applicable regulatory requirements. Includes document change order (DCO) processing, document distribution, and maintenance of the Document Control Database and Document Control Vault.
• Perform Receiving Inspection of incoming units and electronic components.
• Perform QA review for release of products to Finished Goods.
• Perform internal audits as requested.
• Write procedures and test protocols, as assigned.
• Assist with the execution of product validation and verification testing.
• Responsible for ordering and maintaining external standards.
• Two year college degree or equivalent is desired. Four years relevant work experience in a medical device environment may substitute for college degree.
• Minimum two (2) years experience in the manufacturing industry, preferably medical device.
• Strong verbal communication skills and effective writing skills.
• Ability to excel in a team oriented environment.
• Good organization skills and attention to detail.
• Computer skills in word processing and spreadsheets.
• Ability to read engineering drawings.
Nice to have:
• Direct experience with FDA QSR, GMP, MDD & ISO 13485 compliance for the development, validation and manufacture of disposable and durable medical devices.
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.