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Quality System Lead (Head of QMS/ Management Representative), Health China

Apple· Health / Quality Assurance (Apple Health China)
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ShanghaiFull-timePosted 6mo ago

About the role

Principle Quality System Lead to develop and maintain a robust quality system ensuring regulatory compliance and continuous improvement for Health product features in China. Manages internal/external audits, supplier quality, documentation, training, calibration, and post‑market activities, while ensuring registration and regulatory alignment with China medical device requirements.

Responsibilities

  • Develop and maintain a robust quality system to ensure regulatory compliance and continuous improvement.
  • Establishes site specific quality objectives and plans
  • Maintains the quality management system processes by creating / updating standard operating procedures to support regulatory requirements and process changes.
  • Independently supports internal audit program. Schedules audits per an approved schedule, provides objective evidence of conformance to auditors, manages audit finding remediation and closure
  • Supports external audits as the front room lead. Manages audit preparation and execution
  • Oversees the Quality Management Review process and ensures timely execution of management reviews including follow up on action items
  • Regularly report the operation of the quality management system and improvement needs to the legal representative and principal person in charge of the enterprise
  • Manages and supports the supplier quality program. Including but not limited to: identification and qualification of suppliers, supplier corrective actions, and supplier monitoring.
  • Identifies, leads development of, and participates in implementation of new processes
  • Maintains a quality documentation management system
  • Maintains site training system and ensures completion of training for required personnel
  • Maintains calibration system for on site equipment / fixtures
  • Ensures validation of systems and processes; as required
  • Monitors changes to global regulations and ensures policies and procedures reflect applicable changes and implements quality system best practices
  • Oversees adverse event reporting / recalls in country
  • Ensure implementation of post market surveillance systems / reporting
  • Ensure product technical requirements are accurately registered and manufactured product aligns to registration
  • Ensure that products meet release requirements
  • Implement relevant laws, regulations, rules, mandatory standards are implemented. Monitor regulatory landscape for China market and ensure revisions to product / process standards are appropriately implemented.
  • Cooperate with regulatory authorities in supervision and inspection, and organize relevant departments of the enterprise to make timely rectifications in accordance with requirements regarding identified issues.

Qualifications

  • Bachelor’s Degree, or equivalent experience.
  • 7-10 years of experience in Quality Management Systems supporting Medical Devices.
  • Extensive experience in managing, maintaining and implementing quality management systems
  • Excellent written and verbal communication skills
  • Strong customer service orientation and corresponding skills
  • Excellent interpersonal skills working across multiple divisions
  • Attention to detail, well organized and time efficient
  • Can multi-task and work independently
  • Knowledge of domestic medical device regulatory requirements (China GMP)
  • Technical writing skills
  • Proficient in English both oral and written
  • Experience leading and managing regulatory audits
  • Knowledge of international medical device regulatory requirements

Skills

Required:Quality Management System (QMS)Regulatory audits (internal/external)Regulatory knowledge (China GMP/ medical device regulations)Documentation management

Benefits

  • Apple benefits as per standard policies
Last updated Jul 3, 2026. Interested? Apply on the company site.

About Apple

Discover the innovative world of Apple and shop everything iPhone, iPad, Apple Watch, Mac, and Apple TV, plus explore accessories, entertainment, and expert device support.

Discover the innovative world of Apple and shop everything iPhone, iPad, Apple Watch, Mac, and Apple TV, plus explore accessories, entertainment, and expert device support.

AirPods Max 2Apple ArcadeApple CardApple Fitness+Apple MusicApple TVApple TV+Apple Watch Series 11
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