Quality Assurance Production Lead

2 weeks ago

Cupertino, California, United States Apple Full time

Overview:
Weekly Hours: 40

Role Overview:

Join our dynamic team dedicated to enhancing health and wellness through innovative technology for iPhone and Watch. We are committed to creating exceptional products that empower users to lead healthier, more active lives.

The Health Special Projects division is seeking a Quality Assurance Production Lead to manage quality engineering initiatives and support our Quality Management System for medical device offerings.

Key Responsibilities:
You will guide a team of quality engineers to ensure compliance with quality objectives and regulatory standards, including FDA Quality System Regulations, ISO 13485, EU MDR requirements, and risk management protocols.

  • Collaborate with the post-market surveillance team and external stakeholders to enhance product sustainability.
  • Oversee the execution of systems designed to identify and rectify quality issues (CAPAs).
  • Utilize systematic problem-solving techniques to prioritize, communicate, and resolve quality challenges.
  • Ensure thorough investigation and prevention of product and process non-conformance.
  • Support various quality initiatives, including data collection, internal and external audits, training, and procedure documentation.
  • Identify and implement quality improvement strategies in alignment with QMS and regulatory standards.
  • Assist in initiatives as directed by management to uphold Quality Management Systems (QMS) and regulatory compliance.

The Quality Assurance Production Lead must possess the ability to prioritize tasks effectively while maintaining a comprehensive understanding of overarching quality issues. We seek an adaptable individual who can respond promptly and positively to changes.

Strong cross-functional communication skills and experience are essential for success in this role. You will engage with various engineering disciplines and project management teams, ensuring effective communication, adherence to project timelines, and the organization of meetings with actionable items and progress updates.

Minimum Qualifications:

B.S. in Mechanical, Electrical, Biomedical Engineering, Computer Science, or a related field.
10+ years of experience in quality or regulatory roles within the medical device sector.
Familiarity with 21 CFR 820, ISO 13485, ISO 14971, IEC 62366, IEC 62304, and other relevant regulations.
Experience in interpreting requirements and developing standard operating procedures.
Proficient in design control, production and process control, and risk management for medical devices, including the creation and maintenance of design history files.
Expertise in executing design controls and production processes.

Preferred Qualifications:

Experience with software and hardware products in a quality or regulatory context.
Demonstrated ability to work independently and pursue established goals with minimal oversight.
Proven track record in identifying global regulatory requirements for new products and modifications.
Strong organizational and leadership capabilities.
Excellent verbal and written communication skills.

Compensation & Benefits:

At Apple, base pay is just one aspect of our comprehensive compensation package, which is determined within a specified range. This allows for growth and development within your role.

The base pay range for this position is between $146,000 and $243,300, influenced by your skills, qualifications, experience, and location.

Apple employees have the opportunity to participate in discretionary employee stock programs, including restricted stock unit awards and discounted stock purchases through the Employee Stock Purchase Plan.


Additional Benefits:

Comprehensive medical and dental coverage, retirement benefits, discounts on products and services, and reimbursement for certain educational expenses related to career advancement at Apple.

Note: Apple’s benefits, compensation, and employee stock programs are subject to eligibility requirements and other terms of the applicable plan or program. Apple is an equal opportunity employer committed to inclusion and diversity, ensuring 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.

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