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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
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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