Medical Device Quality Operations Lead - Health China at Apple

Shanghai, Shanghai, China -

Full Time

Start Date

Immediate

Expiry Date

28 Jun, 26

Salary

0.0

Posted On

30 Mar, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Medical Device Quality Operations, Regulated Medical Device Software Compliance, Quality Assurance, Regulatory Requirements, ISO 13485, FDA 21 CFR Part 820, EU MDR, Risk Management, Performance Monitoring, Continuous Improvement, Contract Manufacturing Organizations (CMOs), Supplier Quality, China GMP, ISO 14971, IEC 60601, IEC 62304

Industry

Computers and Electronics Manufacturing

Description

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

Responsibilities

This critical role ensures contract manufacturing organizations and critical suppliers adhere to stringent medical device quality and regulatory requirements, focusing on conformance to specified standards, risk management, and continuous improvement within the external supply chain.