Production Quality Engineer - Health at Apple

Cupertino, California, United States -

Full Time

Start Date

Immediate

Expiry Date

03 Jul, 26

Salary

0.0

Posted On

04 Apr, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Engineering, Medical Device Regulations, Risk Management, Design Control, 21 CFR 820, ISO 13485, ISO 14971, IEC 62366, IEC 62304, Issue Resolution, Process Improvement, Project Management, Post-Market Surveillance, Technical Communication, Regulatory Compliance, Design History Files

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 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 Quality team member, who will work 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. The candidate needs to be able to prioritize issues and track the details, as well as be in touch with the big picture issues. We are looking for someone who is flexible and can respond quickly and enthusiastically to changes. This person will interact with all engineering design disciplines and project management teams and will be responsible for managing communications, preserving project schedules, crafting meetings with detailed action items and progress and reporting and presenting to multi-functional teams. The cross-functional social skills and experience are essential to success in this role. MINIMUM QUALIFICATIONS B.S. ME/EE/BME/CS degree or equivalent in any Engineering / Science discipline 3+ 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

Responsibilities

The Production Quality Engineer will oversee quality engineering activities and support quality management system efforts for medical device products. This role involves driving issue resolution, performing risk assessments, and collaborating with engineering and project management teams to ensure compliance and project progress.