Quality Engineer

Redmond, WA 98052

Post Date: 03/29/2018 Job ID: 5539703 Industry: Process Engineer
Overview: Rapidly growing medical device manufacturer is looking to hire an experienced Quality Engineer to provide technical support in a fast paced environment. This flexible position will support multiple areas of Quality Assurance with an emphasis on customer complaints and biological/environmental monitoring. Other areas of support may include methods used for mechanical inspection of precision components, supplier quality, material review board, gage R&R, process capability analysis, product specification review and new product development. Experience/Minimum Requirements: Minimum 3 years experience in the medical device industry with demonstrated quality system knowledge including 21 CFR Part 820 (QSR) & ISO 13485. Bachelor s Degree in an engineering discipline Experience investigating and responding to customer complaints. Experience developing metrics and trending quality data Strong organizational and time management skills. Ability to work independently and amongst a team with minimal supervision. High attention to detail and ability to solve problems and communicate issues. Excellent computer and presentation skills including Microsoft Word, Excel, and PowerPoint.Required Competencies: Works effectively on cross functional teams. Ability to lead continuous improvement activities to resolve quality issues. Excellent written and oral communication skills. Ability to formulate responses to inquiries or complaints from customers. Ability to review, analyzes, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions.Preferred Experience: Experience supporting manufacturing processes including precision machining, injection molding, cleaning, sterilization and passivation. Experience with supplier quality including supplier approval, supplier audits, and SCAR management. Process capability analysis CAPA support from initiation through effectiveness verification Primary Duties & Responsibilities: Investigate and respond to customer complaints under the direction of the Quality Assurance Manager. Coordinate/lead RMA review meetings. Conduct environmental monitoring and out of limit investigations for particle counts and bioburden Conduct biological monitoring and out of limit investigations for sterile product. Provide monthly metrics with corresponding analysis as required Assist with the Material Review Board duties. Ability to lift up to 50 pounds. Other duties as required

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