Production Quality Engineer - Health

Apple • Cupertino, CA

19h

About The Position

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.

Requirements

• 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

Nice To Haves

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees