Production Quality Engineer - Health

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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. ","responsibilities":"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.

Define and implement standard operating procedures (SOPs)

Lead Risk Management activities in relation to design changes, and issues discovered during internal testing, and in the field.

Partner with the Post-Market surveillance team to drive improvements for sustaining products and to establish a risk management process throughout a product's lifecycle.

Lead the execution of systems which identify and resolve Quality issues (CAPAs).

Work with the teams on investigation, resolution and prevention of product and process non-conformances (NC)

Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving Quality issues.

Lead and implement various product and process improvement methodologies in identifying, prioritizing, communicating, and resolving Quality issues.

Identify Quality improvement initiatives in support of QMS and other regulatory requirements.

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

Comply with applicable regulatory requirements, procedures, and processes, requirements

Provide support for other Quality activities and initiatives, quality data collection and trending, internal and external audits, training, authoring procedures, etc.

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

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

Apple is an equal opportunity employer that is committed to inclusion and diversity. We seek to promote equal opportunity for all applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, Veteran status, or other legally protected characteristics. Learn more about your EEO rights as an applicant .

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 $118,500 and $197,500, 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. Learn more about Apple Benefits.

Note: Apple benefit, compensation and employee stock programs are subject to eligibility requirements and other terms of the applicable plan or program.