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Apple Quality Engineer Sustaining - Health United States, California, Cupertino 347388213
13.06.2024
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Description
This person will interact with all engineering disciplines and project management teams. You will be responsible for handling communications, preserving project schedules, crafting meetings with detailed action items and progress, and reporting and presenting to multi-functional teams. You are also responsible for:- Leading risk management activities in relation to design changes, and issues discovered during internal testing, and in the field- Identifying and implementing effective systems to support products post market - Owning 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 in regards to quality issues- 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
Minimum Qualifications
- BS/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 with design control, and risk management activities for medical devices, including development and maintenance of design history files
Preferred Qualifications
- Experience interpreting requirements and following standard operating procedures
- Outstanding organizational and management skills
- Excellent interpersonal skills, both verbal and written
- Experience in working on software products within a quality or regulatory system
Pay & Benefits
- At Apple, base pay is one part of our total compensation package and is determined within a range. This provides the opportunity to progress as you grow and develop within a role. The base pay range for this role is between $107,500 and $179,100, and your base pay will depend on your skills, qualifications, experience, and location.Note: Apple benefit, compensation and employee stock programs are subject to eligibility requirements and other terms of the applicable plan or program.
Apple is an equal opportunity employer that is committed to inclusion and diversity. We take affirmative action to ensure equal opportunity for all applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, Veteran status, or other legally protected characteristics.
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