Quality Engineer III
1 Infinite Loop Permanente, CA 95014 US
Job Description
Job Description:
The Health Special Projects group is looking for a contract Design Quality Engineer to perform sustaining quality engineering activities, and support Quality management system efforts for its software medical device products.
Key Qualifications:
• 3+ years of medical device experience in a quality/regulatory role
• Familiarity with 21 CFR 820, ISO13485, ISO 14971, IEC 62366, IEC 62304 and other applicable regulations
• Experience interpreting requirements and following standard operating procedures
• Experience with design control, and risk management activities for medical devices, including development and maintenance of design history files
• Exceptional organizational and management skills
• Excellent interpersonal skills, both verbal and written
Quality Engineers Are Responsible For:
- Ensuring that Design Controls are properly executed in accordance to established standard operating procedures
- Leading risk management activities in relation to new product development projects
- Identifying and implementing effective systems to support products post market
- Leading the execution of systems which identify and resolve quality issues (CAPAs)
- Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
- Leading and implementing various product and process improvement methodologies
- Leading the investigation, resolution and prevention of product and process nonconformances
- Participating in new product development teams (represent the Quality function as a Core Team Member)
- Supporting initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements.
- Complying with applicable regulatory requirements, procedures, and processes, requirements
Education & Experience:
B.S. ME/EE/BME/CS degree or equivalent in any engineering/science discipline
Additional Requirements-
• Experience in working on software as a medical device (SaMD) products
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