A multinational company from Europe making medical component products,  with more than 70 years of history, about 15+ plants all around the world,  and growing fast , they are now seeking the high caliber as

Company Context

This position is created within a medical device manufacturing entity operating in China, serving both the domestic NMPA-regulated market and international export markets (EU MDR and US FDA). The company is in an active growth phase, scaling its Quality Management System to support new product registrations and entry into regulated export markets.The Quality Manager will play a central role in this scaling journey, working as both an operational leader and a strategic contributor to the Chinese entity management team.

Purpose of the Role

The Quality Manager is the senior quality authority within the Chinese manufacturing site. The successful candidate will own the full quality function — spanning system governance, product quality, design quality involvement, regulatory compliance, and team leadership — while driving the organisation’s readiness for new market registrations and audit success.

Key Responsibilities

1. Quality Management System (QMS) Leadership

• Serve as the Management Representative for ISO 13485 and ISO9001, owning the full QMS lifecycle including document control, internal audits, management review, and CAPA.
• Lead external audits by notified bodies, NMPA inspectors, and customer auditors — independently managing preparation, execution, and post-audit follow-up.
• Drive continuous improvement of the QMS to support scalability across new products and regulated markets.

2. Regulatory Compliance

• Lead and coordinate the NMPA registration process for domestic Chinese market products, including technical dossier preparation and management of regulatory queries.
• Ensure ongoing compliance with ISO9001 and ISO 13485, NMPA regulations, FDA 21 CFR Part 820, and EU MDR requirements applicable to exported product lines.
• Monitor evolving regulatory requirements across target markets and translate them into actionable QMS updates.

3. Design Quality & Product Qualification

• Participate actively in new product development processes, ensuring quality is embedded from design input through design transfer.
• Manage Design History Files (DHF), risk management documentation (ISO 14971), and product qualification protocols in collaboration with engineering teams.
• Own the quality gate process for product launches and ensure design verification and validation meet regulatory expectations.

4. Manufacturing & Cleanroom Quality

• Oversee in-process quality control and final inspection processes across the manufacturing floor.
• Manage the cleanroom environment monitoring programme, ensuring compliance with applicable ISO classifications and internal SOPs.
• Hold stop-production authority when non-conformances pose a quality or compliance risk — escalating to the Asia Operations Director for alignment when cross-functional impact is significant.

5. Supplier Quality Management

• Own the supplier qualification and approval process, including incoming inspection standards and periodic supplier audits.
• Collaborate with procurement to maintain the Approved Supplier List (ASL) and manage supplier non-conformance resolution.

6. Customer Audit Management

• Act as the primary point of contact for customer quality audits from OEM and private-label partners.
• Prepare audit responses and corrective action plans, ensuring timely closure and customer satisfaction.

7. Team Leadership & Development

• Lead, develop, and upgrade the quality team, setting clear objectives aligned with the company’s growth roadmap.
• Define team structure needs and drive recruitment and onboarding of new quality talent as headcount scales.
• Build a quality-first culture across the manufacturing site through coaching, training, and cross-functional engagement.

Candidate Profile

Experience

• Minimum 5 years in a quality management role, with at least 3 years in medical device manufacturing.
• Proven track record managing quality functions for both the Chinese domestic market (NMPA) and at least one export market (FDA or EU MDR).
• Hands-on experience leading ISO 13485 certification and surveillance audits as Management Representative.
• Prior involvement in NMPA product registration processes — ideally including Class II or Class III devices is considered a plus.
• Experience with cleanroom operations and environmental monitoring programmes.
• Background in design quality / design control is strongly preferred.

Technical Knowledge

• Deep knowledge of ISO 13485, NMPA requirements,
• Familiarity with ISO 14971 (risk management) and IEC 62304 (software lifecycle) is an advantage.
• Proficiency with eQMS is considered a plus
• Strong understanding of CAPA methodology, statistical process control, and validation processes (IQ/OQ/PQ).

Leadership & Soft Skills

• Demonstrated ability to operate as both a hands-on quality practitioner and a strategic contributor at management level.
• Confident communicator with the presence and credibility to lead external audits and engage with regulators directly.
• Collaborative, able to exercise stop-production authority constructively and build alignment with operations leadership.
• Strong in team building and capable of attracting, developing, and retaining quality talent.

Languages

• Mandarin: native
• English: professional proficiency