Role : Product Quality Engineer
Work Location : Irvine, CA
Duration of assignment (in Months) : 12 months
Relevant Experience: 5-6 Year in Medical Industry or regulated industry
Technical /Functional Skills
• Quality Engineering working knowledge and Quality Management Experience
• working knowledge of ISO, MDD, FDA QSR 21 CFR 820 / ISO 13485 quality system requirements and the ability to provide an expert knowledge of both regulatory requirements and other compliance areas to minimize risk across product lines
• Strong working knowledge of ISO 14971 Risk Management Process (System Risk Analysis, DFMEA/FMEA and other Risk Management tools)
• Extensive design/sustaining quality experience within medical device industry.
• New product development and post launch support activities, Product remediation and risk management activities
• Working knowledge of Microsoft office products (MS Word, Excel) and Statistical Analysis Software tools
• Writing protocol and reports for design and product validation, and execution
• Engineering change order
• Development of a Standard Procedure (SP), related Work Instructions (WI), Forms, Checklists for design verification and validation activities
Roles & Responsibilities
• Ensure robust technology transfer to products from the development stage to post launch/operations
• Support the development of product, process and packaging requirements in that are complete, compliant and effective
• Ensure product, systems and processes are current in relation to global regulatory requirements
• Work with Core Teams and development partners to ensure robust design quality practices are embedded and applied
• Work with Quality Engineers and project teams to ensure the continued application of Risk Management principles in the post-launch environment
• Partner with Reliability Engineering to ensure that robust design reliability practices are embedded and applied
• Define the controls and quality standards for new products and design changes
• Identify opportunities to continuously improve quality, cost and time factors, consistent with business objectives
• Provide constructive technical challenge to R&D and other technical functions to drive better team performance and project outcomes
• Support organizational development and improvement of the quality system
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