Regional Quality Manager - APAC Distribution, Medical Devices
|Job Title:||Regional Quality Manager - APAC Distribution, Medical Devices|
|Contact Name:||Phua Shyan-Hwei|
|Job Published:||August 13, 2018 09:11|
This is a highly visible role with a strong focus on Regional Continuous Improvement (CI) and will lead and manage the quality operations in the regional distribution centre, ensuring that quality systems complies to the requirements of the relevant standards, corporate and local regulation requirements. You will provide quality management leadership to the DCs in the APAC region to ensure alignment across the region and that the Quality System and processes adequately support the activities and priorities to provide an effective and efficient quality system which creates customer value, addressing elements critical to business success, continuity and competitive advantage.
Some of your key responsibilities include
- Ensure effective implementation and execution of Quality processes conducted under the Quality Systems to accomplish expected requirements and performance in the region DCs.
- Establish and oversee the Quality Agreement between company and 3PL operating DC in Singapore and the region.
- Engage 3PL vendor leadership and provide objectives, direction and coaching to ensure alignment to DC Quality Processes
- Work with company's Supplier Management Audit organisation to coordinate, schedule and conduct Supplier Audits of the 3PL's Quality Processes at the DCs.
- Ensure that processes, organization, procedures and activities in the Distribution Centres' QMS system in the APAC region are harmonized and adequate to effectively meet the needs for the organisation and conform to all applicable regulatory requirements, and the Quality Agreement.
- Establish and enforce Quality process performance metrics for the 3PL to be used in conjunction with the Operational performance metrics established within the existing DC Quality Agreement.
- Responsible for collecting, trending, analysing and disseminating DC metrics
- Initiate, investigate, track, follow-up and close non-conformance and corrective/preventive actions.
- Employ best practices and CI tools to accelerate continual quality improvement into the regional DC organisation.
- Assume the role of company's internal auditor to ensure compliance with the applicable procedures.
Degree qualified with a Bachelor's Degree in Science, or Engineering Discipline, you will have at least 8 years relevant quality assurance experience and experience in supply chain/warehouse quality systems. You will have minimum 3 years in leading and managing people/projects and a CI Black Belt is strongly preferred. You have relevant experience in quality systems for complaint management, failure investigation, CAPA and document & quality records management, and demonstrated knowledge to perform ISO13485 audits. Knowledge in GDPMDS, ISO 13485 or US FDA QSR will be an added advantage. This is a role focused on building CI culture in the region and the successful candidate should possess the drive and commitment to drive the culture of CI transformation.
Singapore Employment Agency Licence No: 16S8069
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