Quality System Lead - Head of QMS/ Management Representative

Summary

Apple is where individual imaginations gather together, committing to the values that lead to great work. Every new product we build, service we create, or Apple Store experience we deliver is the result of us making each other’s ideas stronger. That happens because every one of us shares a belief that we can make something wonderful and share it with the world, changing lives for the better. It’s the diversity of our people and their thinking that inspires the innovation that runs through everything we do. When we bring everybody in, we can do the best work of our lives. Here, you’ll do more than join something — you’ll add something. 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 group is looking for a Principle Quality System Lead to support regulated features in China. 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.

Minimum 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

Preferred Qualifications

Knowledge of international medical device regulatory requirements

Description

Develop and maintain a robust quality system to ensure regulatory compliance and continuous improvement. Supports region specific manufacturing registrations Guides team members on the implementation of the quality system requirements.

Responsibilities

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.