My client is a leader in the R&D and life science industry and is going through a period of rapid expansion and change transformation. To cater to this change, a new Product Quality Manager is required to come on board.
As the Product Quality Manager, the incumbent will have complete oversight of product quality and collaborate with cross functional teams to drive quality initiatives to achieve objectives
Responsibilities:
- Manage Product Quality to meet quality and relevant regulatory requirements.
- Lead in the development and implementation of quality initiatives to address product, process and system inadequacies.
- Act as a key figure in new product introduction and transfer projects
- Guide and mentor the product quality team to support plant wide activities, projects and quality initiatives
- Ensure timely investigation of nonconformance / customer complaints and implementation of effective corrective action
- Participate in CAPA meetings to identify adverse trends in product quality performance and facilitate the initiation of corrective and preventive actions.
- Ensure adherence to quality and safety standards and ensure alignment to business objectives
Requirements:
- Advanced Degree in Engineering, Quality, Biotechnology or equivalent with at least 6- 10 years' experience in a medical device environment
- Excellent knowledge of Quality Management System (ISO 13485/FDA 21 CFR Part 820)
- Prior experience in dealing with customer complaints and CAPA
- Experience with life science instruments will be preferred (IVD, GCMS, pCR)
- Trained Lead/Internal Auditor in ISO 13485 preferred
- Box build experience from contract manufacturers will be a big plus
- Demonstrated ability in leadership and change management
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).
