Industry Leader, Carrier growth, amazing benefits, Generous compensation.
This Jobot Job is hosted by: Eric Holmes
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Salary: $100,000 - $150,000A bit about us:
We are ranked number # 3 in FDA approved Medical Device companies in the United States and are expanding our team in the Bay Area. Do you have what it takes?Why join us?
Carrier growth, amazing benefits, generous compensation.Job Details
About the Team:
The Senior Quality Engineer is responsible for the quality assurance of product design and supplier controls / performance. He / she must understand and be able to implement the relevant requirements of the Quality System Regulation (21 CFR 820) and ISO 13485. He/she initiates and facilitates improvements to the quality system while providing technical support to R&D, Manufacturing, and Supply Chain. This position serves as a Quality representative on new product development and provides technical support and leadership of quality deliverables.
Also responsible to support R&D and Operations during all product development phases and support creation of design controls as well as process qualification/validation activities, statistically sound sampling plans and process control plans including inspection/test method development and product investigations resulting from field complaints. Ensure that vendors / suppliers deliver quality products, materials, and services in accordance with specifications, purchase orders, and quality agreements. Monitor parts from purchasing through the manufacturing cycle. Communicates and resolves supplier-related problems as they occur.
Assists in evaluating suppliers’ performance and provides feedback. Support activities associated with supplier quality within a medical device environment. Collaborates with Regulatory, Supply Chain, Quality, Manufacturing, Engineering, and Customer Support for compliance to all specifications. Develops, applies, and reviews procedures in accordance with 21 CFR 820 and ISO 13485. Collaborates with new & existing product development teams to ensure quality standards are met. Support and/or lead supplier quality activities such as supplier qualification, supplier audits, inspection plans, root cause analysis, CAPA investigation, and supplier performance monitoring.
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New Product Development
Title 21 Of The Code Of Federal Regulations
Corrective And Preventive Action (Capa)