About the role
Summary
Apple is where individual imaginations gather together, committing to the values that lead to great work. Every new product we build, service we create, or Apple Store experience we deliver is the result of us making each other’s ideas stronger. That happens because every one of us shares a belief that we can make something wonderful and share it with the world, changing lives for the better. It’s the diversity of our people and their thinking that inspires the innovation that runs through everything we do. When we bring everybody in, we can do the best work of our lives. Here, you’ll do more than join something — you’ll add something. Our ever-evolving suite of Heath and Wellness products for iPhone 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 Medical Device Quality Operations Lead to support regulated medical device software compliance. 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 Medical Device Quality Operations Lead (External) is part of the Quality Organization supporting Apple’s medical products. The role is expected to work closely with cross functional teams to ensure product conforms to specified requirements. This role is a critical role responsible for ensuring that contract manufacturing organizations (CMOs) and other critical suppliers meet the stringent quality and regulatory requirements of the medical device industry (e.g., ISO 13485, FDA 21 CFR Part 820, EU MDR). This role focuses on conformance to specified requirements, implementation and maintenance of required standards, risk management, performance monitoring, and continuous improvement in the external supply chain.
Minimum Qualifications
Education ~ Bachelor’s degree in Engineering, Life Sciences, or a related technical field (Master’s preferred). 10+ years of Medical device experience in a Quality/Regulatory role. Experience interpreting requirements. Excellent written and verbal communication skills. Excellent interpersonal skills working across multiple divisions. Strong negotiation, cross-functional leadership, and "firm but fair" communication. Attention to detail, well organized and time efficient. Knowledge of domestic medical device regulatory requirements (China GMP), ISO13485, ISO 14971, IEC 60601, IEC 62366, IEC 62304 and other applicable regulations. Proficient in English both oral and written.
Preferred Qualifications
Experience working on software medical device products within a Quality or regulatory system. Proven background in being autonomous and being able to clearly work towards establish goals and initiatives with minimal oversight. 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. Ability to take initiative in an ambiguous and fast fast paced environment. Strong organizational, time management, and influence skills Knowledge of international medical device regulatory requirements
Aplyr's read
Apple is a tech giant known for its sleek design and innovation, attracting top talent in engineering, design, and business operations.
What's promising
- •Apple consistently leads in tech innovation with a strong focus on design and user experience.
- •The company's global brand recognition offers employees a prestigious platform for career growth.
- •Apple's robust ecosystem integrates hardware, software, and services, creating diverse job opportunities.
What to watch
- •High-pressure work environment with demanding deadlines can impact work-life balance.
- •Apple's secretive culture may limit transparency and cross-departmental communication.
- •Dependence on hardware sales makes the company vulnerable to market saturation risks.
Why Apple
- •Apple's design philosophy emphasizes simplicity and elegance, setting it apart in the tech industry.
- •The company has a unique retail presence with its own stores enhancing customer experience.
- •Apple's closed ecosystem creates a seamless integration across its products, unmatched by competitors.
Aplyr’s read is generated by AI from public sources. Was it useful?
About Apple
Apple Inc. is a leading technology company known for its innovative consumer electronics, software, and services. The company designs and manufactures products such as the iPhone, iPad, Mac computers, and wearables, significantly influencing the tech industry and consumer behavior worldwide.
