Medical Device Quality Operations Lead - Health

ologies 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 group is looking for a Medical Device Quality Operations Lead to support regulated medical device software compliance. If you are passionate about the health space and want to have an incredible impact here at Apple, this could be the role for you. We are an efficient organization who works closely together to establish relationships across multiple functional teams. We care deeply about getting amazing new products into our customers hands.

Description
The Medical Device Quality Operations Lead (External) is part of the Quality Organization supporting Apple's medical products. The role is expected to work closely with cross functional teams to ensure product conforms to specified requirements. This role is a critical role responsible for ensuring that contract manufacturing organizations (CMOs) and other critical suppliers meet the stringent quality and regulatory requirements of the medical device industry (e.g., ISO 13485, FDA 21 CFR Part 820, EU MDR). This role focuses on conformance to specified requirements, implementation and maintenance of required standards, risk management, performance monitoring, and continuous improvement in the external supply chain.","responsibilities":"Ensure quality system management processes, to support regulatory requirements and process changes, are appropriately implemented.

Provide quality oversight for key external partners. Lead technical quality discussions and ensure that production processes remain in a state of control.

Ensure quality issues are identified, escalated and dispositioned in a timely manner.

Plan and execute audits. Ensure that external partners maintain compliance with global regulatory standards and internal quality agreements.

Ensure processes are well defined and integrated with Apple Quality system processes.

Lead the investigation of complex deviations, non-conformances, and other quality issues originating from external sites. Oversee the implementation of effective Corrective and Preventive Actions (CAPAs).

Ensure proposed changes from suppliers (materials, processes, or equipment) are reviewed and approved prior to implementation to ensure no adverse impact on product safety or efficacy.

Draft, negotiate, and maintain Quality Agreements (QAs) with external partners to clearly define roles and responsibilities.

Ensure risks are identified and mitigated within the external manufacturing process.
Develop and monitor Quality Key Performance Indicators (KPIs) for suppliers, leading periodic Quality Reviews.

Identify, lead development of, and participate in implementation of new processes.

Monitor changes to global regulations and ensure policies and procedures reflect applicable changes and implement quality system best practices.

Preferred Qualifications
Experience working on software medical device products within a Quality or regulatory system.
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. Ability to take initiative in an ambiguous and fast fast paced environment.
Strong organizational, time management, and influence skills
Knowledge of international medical device regulatory requirements

Minimum Qualifications
Education ~ Bachelor's degree in Engineering, Life Sciences, or a related technical field (Master's preferred).
10+ years of Medical device experience in a Quality/Regulatory role.
Experience interpreting requirements.
Excellent written and verbal communication skills.
Excellent interpersonal skills working across multiple divisions.
Strong negotiation, cross-functional leadership, and "firm but fair" communication.
Attention to detail, well organized and time efficient.
Knowledge of domestic medical device regulatory requirements (China GMP), ISO13485, ISO 14971, IEC 60601, IEC 62366, IEC 62304 and other applicable regulations.
Proficient in English both oral and written.