My client is a global name in the medical device industry and now seek an experienced QA Manager to oversee cross functional teams and manage product quality functions and drive quality initiatives
The incumbent will eventually be considered for the Site Quality Head role
- Global Name
- Leadership Role
- Attractive Remuneration
Responsibilities:
- Lead and support the development of the organization's ISO 13485 and FDA 21 CFR part 820 compliance by providing the necessary guidance and leadership
- Assume responsibility for site quality compliance initiatives and programs
- Review, develop and, implement all quality policies and procedures to ensure product conformity with corporate specifications and industry standards.
- Manage quality and compliance metrics with target and corporate initiatives to improve overall effectiveness
- Manage field response rate and ensure corrective actions are implemented throughout manufacturing site
- Ensure appropriate communication on Quality issues and Regulatory compliance issues with external vendors and customers and compliance authorities
- Report to executive management for Quality performance for QMS, Quality performance, Non-conformities & Audit results
- Develop and review talents gaps within the Quality organization and manage talent accordingly
Requirements:
- Advanced Degree in Engineering, Science or equivalent with at least 10 years' experience in a QA Function from a regulated industry
- Experience in design and manufacturing of medical instruments
- Prior exposure in FDA Audits
- Able to think strategically, creatively and rationally
- Ability to lead and manage a high performing team
- Strong communication and ability to negotiate with leaders
Please send your resume in WORD format by clicking the apply button below or contact Abhik Damani on +65 6701 1527 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1544061 (Abhik Damani).
