
Software Design Quality Engineer
Provides leadership for engineers supporting new product development. As a Quality Core Team member, collaborate with cross-functional project team members as well as members of the QA extended team. Demonstrate the ability and desire to work within a regulated medical device development environment, particularly based on the FDA Quality System Regulation and ISO 13485. Ensure internal Design Control policies and procedures comply with regulations and external standards, including software regulations, risk management, and change control. Identify and implement process improvements to increase efficiencies and product quality. Lead and drive collaborative design and development of medical devices. Collaborate and develop system hazard analysis. Lead and drive CAPA projects.
5+ years of work experience in Quality, Engineering and/or Software Development.
Experience working in a regulated industry (e.g., FDA-regulated)
Working knowledge of embedded and mobile application development for medical devices
Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 62304, IEC 60601-1 and MD
Documentation
Risk Management
Time Management
Validation and testing skills
System hazard analysis
Author technical reports
Process Improvement
Verbal communication
written communication
Self-Motivated
Adaptability and Creativity
According to JobzMall, the average salary range for a Software Design Quality Engineer in 18000 Devonshire St, Northridge, CA 91325, USA is between $70,000 and $110,000 per year. This range may vary depending on the experience and qualifications of the individual engineer.
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Medtronic plc is the world's largest medical device company that generates the majority of its sales and profits from the US healthcare system and is headquartered on the island of Ireland.

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