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Our ever-evolving suite of Heath and Wellness products for i Phone and Watch are helping our users live more active, healthier lives. Be ready to make something great when you come here. Dynamic, inspiring people and innovative, industry-defining technologies are the norm at Apple. The people who work here have reinvented and defined entire industries with our products and services. The same dedication to innovation also applies to our business practices -strengthening our commitment to leave the world better than we found it.

The Health group is looking for a Manager of the QMS Engineering team 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.

Description

The QMS Engineering Manager will be responsible for overseeing a team of engineers responsible for the validation of all non-product software used in the design and production of medical devices. Beyond maintaining a compliant state, this leader is responsible for optimization by implementing automation and AI. This team manages the tools and systems that build the product.

This person will oversee a team of validation engineers responsible for the optimization of the quality management system (including non product software) and managing the lifecycle of the software systems. This includes the following activities:

• Non product software validations

• QMS Process Optimization

• Integration of AI in the quality management system","responsibilities":"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. This role allows the organization to adopt new technologies (like AI-driven QMS) faster than competitors while maintaining an impeccable compliance profile.

Ensure all non-product software and processes comply with regulatory requirements.

Ensure projects have defined plans, objectives and goals. Monitor progress to ensure on time delivery and results

Develop a team of high-performing professionals. Foster a "Critical Thinking" culture where the team is empowered to scale efforts based on risk Support internal and external audits as the SME for non product software

Preferred Qualifications

Excellent written and verbal communication skills

Experience presenting to executive management

Excellent interpersonal skills working across multiple divisions

Attention to detail, well organized and time efficient

Can multi-task and work independently

Experience with software as a medical device

PMP Certification

Minimum Qualifications

Bachelor's Degree or equivalent experience

10+ years of experience in Quality Management Systems supporting Medical Devices

Six Sigma Green/Black Belt

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

Ability to influence stakeholders to adopt modern techniques

Experience with AI/ML:

Experience with eQMS software

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 $148,900 and $248,200, 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.