Senior QMS Development Engineer - Medical Devices
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Description
The Health group is looking for a Senior QMS Development Engineer to support regulated medical device features. If you are passionate about the health space and want to have an incredible impact here at Apple, this could be the role for you. We are an efficient organization who works closely together to establish relationships across multiple functional teams. We care deeply about getting amazing new products into our customers hands.
The Senior QMS Development Engineer will be responsible for designing, implementing, and optimizing quality system processes that ensure our quality management system meets global regulatory requirements in an efficient manner.
This is a site-based role. ","responsibilities":"Lead the development and continuous improvement of Quality Management System (QMS) processes. Use Lean and Six Sigma methodologies to eliminate "compliance waste" while maintaining strict adherence to standards.
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Develop strategies and tools to ensure alignment of quality processes across multiple sites while accounting for local regional requirements (e.g., China GMP).
Work with cross functional teams to define and evaluate processes
Leverage statistical methods to analyze data to characterize process performance in order to minimization sources of variation.
Apply Lean methodologies to systematically identify and eliminate process inefficiencies and non-value-added activities, ensuring the development of efficient, cost-effective systems.
Develop, implement, and maintain improved processes that are in compliance with relevant industry regulations and standards (e.g., FDA, ISO 13485, China GMP).
Evaluate emerging technologies and state-of-the-art industry practices related to quality management systems, driving the adoption of innovative solutions to optimize execution and process capabilities.
Preferred Qualifications
Experience with software as a medical device
Experience with eQMS software
Excellent interpersonal skills working across multiple divisions
Attention to detail, well organized and time efficient
Can multi-task and work independently
Minimum Qualifications
Bachelor's Degree, or equivalent experience.
7+ years of experience in Quality Management Systems supporting Medical Devices.
Six Sigma Green/Black Belt.
Excellent written and verbal communication skills
Experience presenting to executive management
Knowledge of medical device regulatory requirements (e.g. ISO13485, MDSAP requirements, China GMP, EU MDR etc...)
Strong project management skills-ability to lead cross-functional teams without direct authority.
Experience with AI/ML
Apple is an equal opportunity employer that is committed to inclusion and diversity. We seek to promote 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. Learn more about your EEO rights as an applicant .
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 $146,300 and $244,100, and your base pay will depend on your skills, qualifications, experience, and location.
Apple employees also have the opportunity to become an Apple shareholder through participation in Apple's discretionary employee stock programs. Apple employees are eligible for discretionary restricted stock unit awards, and can purchase Apple stock at a discount if voluntarily participating in Apple's Employee Stock Purchase Plan. You'll also receive benefits including: Comprehensive medical and dental coverage, retirement benefits, a range of discounted products and free services, and for formal education related to advancing your career at Apple, reimbursement for certain educational expenses - including tuition. Additionally, this role might be eligible for discretionary bonuses or commission payments as well as relocation. Learn more about Apple Benefits.
Note: Apple benefit, compensation and employee stock programs are subject to eligibility requirements and other terms of the applicable plan or program.
Perks and Benefits
Health and Wellness
Parental Benefits
Work Flexibility
Office Life and Perks
Vacation and Time Off
Financial and Retirement
Professional Development
Diversity and Inclusion
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