Quality Assurance Specialist
11911 North Creek Parkway South Bothell, WA 98011
Position Title: Quality Assurance Specialist
Position Description: Our Bothell Client has a need for a Quality Assurance Specialist for a full-time role.
Perform quality engineering and quality system related tasks to support the design, development, and production of medical device systems.
Support in the following Quality Systems:
- Administer and maintain the Calibration system.
- Assist with Corrective Action and Preventative Action (CAPA) investigations and reporting.
- Support Document Control to comply with quality systems 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 catheter 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.
- 2 year college degree or equivalent required. 4 years relevant work experience in a medical device environment may substitute for college degree.
- Minimum 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.
- 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.