A global renowned US medical devices manufacturer is looking for highly driven and meticulous QMS manager with strong passion in managing and improving quality systems. Reporting into the Quality Director, you will be responsible to lead the QMS team, ensuring products are manufactured in compliance to quality systems standards and engage in continuous improvements of the systems.
Responsibilities
- Leads the QMS team to ensure compliance with international medical devices standards, i.e. ISO 13485, MDD, ISO 9001, FDA 21 CFR part 820 and other requirements.
- Establishes and supports initiatives to identify areas of improvements and prevention measures on quality systems.
- Responsible in leading QMS processes such as non-conformance issues management, CAPA, training, audits, document and change controls, etc.
- Participates in non-conformance investigations and conduct meetings to review and drive effective and timely closure of CAPA
- Establishes and implements quality audit program, ensuring audit readiness and supports external audits
Requirements
- Degree in Science or Engineering with at least 6 years of quality management experience in medical devices or pharmaceutical space
- Prior exposure to leading a team is highly advantageous
- Strong expertise with ISO 13485, FDA, MDD and related medical devices quality standards with past exposure to quality audits, continuous improvement projects and GMP
- Strong communications and influential skills to work effectively with different stakeholders to drive improvements to quality systems
Please send your resume in WORD format by clicking the apply button below or contact Kareen Wong on +65 6701 1518 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1878552 (Wong Yin Ling, Kareen).
