About the role

Aplyr's Quick Take

This role is about ensuring the quality of medical devices at Apple, focusing on compliance with regulations and improving processes. You'll work closely with engineering and project management teams to resolve issues and implement quality improvements. It's primarily an individual contributor role with a strong emphasis on technical expertise in quality engineering.

Good fit

Ideal candidates have at least 5 years of experience in quality or regulatory roles within the medical device industry, with a solid understanding of relevant regulations. A detail-oriented, proactive approach and strong communication skills will help you thrive here.

Worth noting

The position is site-based, which may not suit those looking for remote work. The emphasis on cross-functional collaboration suggests a dynamic work environment, but the role's specific day-to-day responsibilities are not fully detailed.

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 Special Projects group is looking for a Production Quality Engineer to oversee Quality engineering activities, and support quality management system efforts for its medical device products. We’re looking for innovative thinkers and doers who are passionate to make a real impact in people’s lives.

Description

We are looking for a cross-functional Quality team member, working closely with Engineering, Project management, and Post-Market surveillance teams. This role is critical in driving product and process issue resolution, implementing Quality improvements, performing risk assessments, and ensuring clear communication and timely progress reporting across teams. This person will 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, while defining and implementing standard operating procedures (SOPs). This is a site-based role.

Minimum Qualifications

B.S. ME/EE/BME/CS degree or equivalent in any Engineering/Science discipline 5+ 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

Preferred Qualifications

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 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.

Skills & Tags

product

Aplyr's read

Apple is a tech giant known for its sleek design and innovation, attracting top talent in engineering, design, and business operations.
Synthesized from recent postings & public sources

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

apple.com

View company

AAPL$298.01+0.70%

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.