Formulate the overall quality policy, set stringent quality goals, and maintain full accountability for quality management across all MedTech injection molding operations.
Implement, maintain, and optimize a robust Quality Management System (specifically ISO 13485 and FDA 21 CFR Part 820). Develop medium-to-long-term quality plans to ensure continuous operational excellence and regulatory compliance.
Host major quality task forces, coordinate across departments, and drive significant quality improvement and cost-reduction initiatives without compromising medical-grade standards.
onduct rigorous product audits and effectively monitor process quality indicators for precision injection molding. Ensure that all products transitioning into mass production meet strict delivery and quality targets.
Strengthen internal quality firewalls (such as IPQC and advanced containment protocols) to strictly block the outflow of defective products, mitigate risk, and minimize external quality costs.

Bachelor's Degree in Mechanical Engineering, Plastics Engineering, Quality Management, or a related technical field.
15+ years of progressive experience in overall manufacturing quality management, with a mandatory and deep background in Medical Device Manufacturing and Plastics Injection Molding
A solid grasp of Lean Manufacturing or Six Sigma methodologies is required (Green/Black Belt or Lean Practitioner certifications are a big plus)
Extensive, hands-on knowledge of MedTech regulatory requirements. Highly proficient in ISO 13485 and FDA 21 CFR Part 820. (Familiarity with broader ISO/TS systems such as ISO 9001, ISO 14001, and automotive standards like IATF 16949, VDA 6.3, or TS 16949 is highly advantageous).

If you are interested in the position, kindly apply to this job or send your CVs to yitwei.kwan(@)randstad.com.sg

We regret that only shortlisted candidates will be contacted

EA: 94C3609 / R1325913

Plastics Injection Senior Quality Director(Medtech ISO13485)