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Apple Production Quality Engineer - Health United States, California, Cupertino 980065713
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- Ensure that products meet Quality goals, and regulatory requirements including but not limited to FDA Quality System Regulations, ISO 13485, EU MDR requirements, and Risk Management per ISO 14971. • Define and implement standard operating procedures (SOPs)• Leading Risk Management activities in relation to design changes, and issues discovered during internal testing, and in the field.• Partner with the Post-Market surveillance team to drive improvements for sustaining products and to establish a risk management process throughout a product’s lifecycle.• Leading the execution of systems which identify and resolve Quality issues (CAPAs).• Working with the teams on investigation, resolution and prevention of product and process non-conformances (NC)• Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving Quality issues.• Leading and implementing various product and process improvement methodologies in identifying, prioritizing, communicating, and resolving Quality issues.• Identify Quality improvement initiatives in support of QMS and other regulatory requirements.• Supporting initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements.• Aligning with applicable regulatory requirements, procedures, and processes, requirements • Provide support for other Quality activities and initiatives, quality data collection and trending, internal and external audits, training, authoring procedures, etc.This is a site-based role.
- B.S. ME/EE/BME/CS degree or equivalent in any Engineering / Science field
- 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
- Experience working on software and hardware products within a Quality or regulatory system.
- Expertise in execution of design controls.
- Proven background in being autonomous and being able to clearly work towards establish goals and initiatives with minimal guidance.
- Demonstrated competence in determination of appropriate global regulatory requirements for new products or product changes.
- Strong organizational and leadership skills.
- Excellent communication skills, both verbal and written.
Note: Apple benefit, compensation and employee stock programs are subject to eligibility requirements and other terms of the applicable plan or program.
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