Quality Engineer, Sustaining - Health

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 Quality Engineer to perform sustaining quality engineering activities, and support Quality management system efforts for its software medical device products.

Description

The Quality Engineer 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 disciplines and project management teams. You will be responsible for handling communications, preserving project schedules, crafting meetings with detailed action items and progress, and reporting and presenting to multi-functional teams. You are also responsible for:

• Leading risk management activities in relation to design changes, and issues discovered during internal testing, and in the field

• Identifying and implementing effective systems to support products post market

• Owning the execution of systems which identify and resolve quality issues (CAPAs)

• Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues

• Leading and implementing various product and process improvement methodologies in regards to quality issues

• Working with the teams on investigation, resolution and prevention of product and process non-conformances

• Supporting initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements

• Aligning with applicable regulatory requirements, procedures, and processes, requirements

Minimum Qualifications

• BS/ME/EE/BME/CS degree or equivalent in any engineering/ science field

• 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 with design control, and risk management activities for medical devices, including development and maintenance of design history files

Preferred Qualifications

• Experience interpreting requirements and following standard operating procedures

• Outstanding organizational and management skills

• Excellent interpersonal skills, both verbal and written

• Experience in working on software products within a quality or regulatory system

Pay & Benefits

• At Apple, base pay is one part of our total compensation package and is determined within a range. This provides the opportunity to progress as you grow and develop within a role. The base pay range for this role is between $107,500 and $179,100, and your base pay will depend on your skills, qualifications, experience, and location.

Apple employees also have the opportunity to become an Apple shareholder through participation in Apple's discretionary employee stock programs. Apple employees are eligible for discretionary restricted stock unit awards, and can purchase Apple stock at a discount if voluntarily participating in Apple's Employee Stock Purchase Plan. You'll also receive benefits including: Comprehensive medical and dental coverage, retirement benefits, a range of discounted products and free services, and for formal education related to advancing your career at Apple, reimbursement for certain educational expenses - including tuition. Additionally, this role might be eligible for discretionary bonuses or commission payments as well as relocation.