Job Description Summary
**Job Description**:
Who We Are
Job Responsibilities
- Supporting Sr. Director of Manufacturing & Design Quality, Greater Asia to provides managerial and technical support to the Greater Asia Manufacturing plants and Design Centers (Unit Quality).
- Accomplishes tasks through highly experienced professional specialists or managers.
- Work as part of the Leadership team to support Sr Director, sponsoring innovative ideas to improve Quality and Supplier Quality operation, by recommending, supporting and implementing continuous improvement activities in processes and procedures to optimize results to improve quality of delivery, meeting quality standards requirements deliverable in line with Company and Customer requirements.
- Support activities relating to Field Corrective Actions, when needed. Collaborating and gathering data from plants and unit quality organization to identify and interpret performance trends/ Metrics.
- Support in design transfer activities for complex NPI projects in collaboration with cross-functional stakeholders including R&D, Supply Quality, Supply Chain/Procurement, Technical Operations, Manufacturing plant and plant Quality across Greater Asia Region.
- Provide guidance and Quality oversight of all key quality leads to ensure suppliers to manufacturing plants are aligned with company, regulatory and meeting industry standard requirements.
- Monitor Greater Asia Region Plant Quality and Supplier Quality performance/ metrics. Lead Greater Asia Plant Quality and Supplier Quality Review meeting quarterly within the region on supplier performance data and defined required actions plan for supplier improvements implement within manufacturing plant.
- Develop and implementation the quarterly/annual Greater Asia Plant Quality Performance Excellent program.
- Act as Subject Matter Expect to support FDA inspection and Governments’ regulatory audit.
- Any other assignment assigns by the direct manager.
Our Requirements
- At least 8-10 years of working experience in Quality function with managerial experience
- Six Sigma black belt and certified ASQ Quality Manager or equivalent.
- Demonstrated high level of ability in applicable to FDA, European and other relevant clinical/regulatory requirements, including ISO 9001 and 13485, IVDR/MDR, 21 CFR 820 Quality System Regulation, EU MDR, IVDR, etc.
- Experience in preparing, hosting and lead FDA and other Governments’ Regulatory inspection.
- Ability to work in a highly matrixed and geographically diverse business environment preferred.
- Strong leadership and communication skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
- Capable of managing a range of projects and activities in parallel and work with a diverse team at multiple locations within Greater Asia Region.
- Certified ISO 13485 Lead Auditor is a must.
- Ability to travel as required.
- Culture and Benefits
- Here at BD, we embrace a growth mindset, building capabilities for the future and helping you become the best version of yourself. We offer our employees a clear direction and career pathway for development. We pride ourselves on our transparent and rigorous talent processes that are inclusive, deeply embedded in trust, aligned with our culture, and enable us to achieve strategic imperatives of the organization. Our leaders are committed, engaged and accountable to making talent our top priority.
- How To Apply
Primary Work Location
SGP The Strategy
Additional Locations
Work Shift