Quality Manager

Job description

Position overview We are seeking a hands-on and strategical quality manager to lead Suzhou quality department. The ideal candidate would be a strategic thinker (growth mindset) who can look beyond quality to see the bigger business picture. Beyond ensuring compliance with stringent medical device regulations, the candidate is expected to act as a key driver for operational excellence and business growth, transform our quality function to a competitive advantage that enables market expansion and earns customer trust.

Key responsibilities & expectations Leadership & team development Team leadership: lead, mentor and develop quality team (IQC, IPQC, QA, QC). Foster a culture of accountability, continuous improvement and technical excellence.

Change management

Change the department’s mindset from mere inspection to proactive prevention. Improve workflows and enhance collaboration with Production, Engineering, and other cross functions.

Talent Building

Identify skill gaps within the team and implement training programs to elevate the overall competency.

System Enhancement & Compliance (The Foundation) QMS Mastery

Own, maintain and improve our QMS in strict compliance with ISO 13485 and FDA QSR (21 CFR Part 820).

Process Validation

Oversee IQ/OQ/PQ activities, involved in early-stage project development and lead quality requirement discussion with customers.

Risk Management

Champion risk management (ISO 14971) throughout the product lifecycle to mitigate hazards before they impact the business.

Audit Readiness

Serve as the primary liaison during external audits (Notified Bodies, FDA, and key customers). Ensure zero critical findings and timely closure of any observations. Business Growth & Strategic Contribution (The Differentiator)

Connecting Quality to Business Outcomes

Utilize quality metrics to demonstrate value to stakeholders. Understand how quality performance affects customer retention, pricing power, and market access.

Customer Interface

Serve as quality partner for key accounts. Communicate our quality rigor effectively to secure new contracts and pass stringent customer audits.

Market Expansion Support

Ensure our systems meet specific requirements for target markets (EU MDR, NMPA, etc.)

Cost of Quality

Analyze quality costs and drive initiatives to reduce scrap, rework, and claims, thereby directly improving profitability Operational Excellence Supplier Quality: Strengthen supplier qualification and monitoring processes to ensure the consistency of raw materials CAPA Leadership: Drive the Corrective and Preventive Action (CAPA) process to ensure root causes are identified and eliminated, preventing recurrence Data-Driven Decisions: Utilize statistical methods (SPC, MSA) to monitor process stability and make informed decisions regarding process improvements. e.

Continuous Improvement, Innovation & Proactive Leadership (The Growth Driver) Champion continuous improvement initiatives throughout the site. Drive measurable improvements in quality, productivity, cost reduction, and customer satisfaction. Proactive Quality Leadership by Anticipating quality and compliance risks before they become issues. Utilize trend analysis, leading indicators, and risk-based thinking to identify improvement opportunities and prevent problems rather than reacting to them after occurrence.

Promote Innovation and Digitalization with adoption of new technologies, automation, and digital quality tools to improve efficiency, data visibility, and decision-making. Leverage AI, statistical analysis, and process intelligence to enhance quality performance. Challenge the status quo and drive sustainable solutions to complex quality and operational challenges. Foster a culture where employees actively seek opportunities for improvement.

Act as a change agent across the organization, influencing operations, engineering, supply chain, and leadership teams to continuously improve business performance and customer outcomes. Establish and monitor meaningful KPIs that drive accountability, organizational learning, and continuous improvement across all quality

Qualifications & Skills

Required Education: Minimum bachelor’s degree in engineering, Chemistry, Polymer Science, or related field.

Experience

Minimum 8 years of quality experience in the medical device industry Proven track record in a managerial role within a regulated manufacturing environment.

Technical Expertise

Deep knowledge of ISO 13485, FDA regulations, GMP and cleanroom standards (ISO Class 7).

Soft Skills

Strong leadership presence with excellent communication skills in both English and Chinese (required for this role); Ability to influence stakeholders at all levels—from the shop floor to the executive suite; A proactive mindset focused on solutions rather than just identifying problems.