Quality Manager

1. 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.

1. Key responsibilities & expectations

1. 1. 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 departments 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.

1. 1. 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.

1. 1. 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

1. 1. 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

1. Qualifications & Skills Required

• Education: Minimum bachelors 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 levelsfrom the shop floor to the executive suite; A proactive mindset focused on solutions rather than just identifying problems.