BD (Becton, Dickinson and Company) (Senior) Supplier Quality Engineer in Tuas, Singapore

Job Description Summary

The (Senior) Supplier Quality Engineer (SQE) is responsible and accountable for quality engineering support of OEM and Component suppliers for Class II Medical Device Instrumentation. The SQE is the Technical liaison for all quality related aspects of supplier management. In addition, the SQE will partner with Operations, Design site, and Procurement groups to execute and monitor Supplier Management processes and strategies, and drive partnership and collaboration with the supply base. The candidate must be capable of self-direction, time management, and project management to ensure successful results achieving business objectives. The SQE must be data driven in decision making, ability to drive value add quality initiatives, and focus on Performance/Metrics data for preventative and correction action measures. Due to multiple supplier locations in Asia, extensive travel will be involved.

Job Description

• Provide guidance and Quality oversight for key suppliers to ensure suppliers are aligned with BD Quality, Regulatory and Industry standard requirements. Ensure controls meet BD, FDA, and other applicable regulatory requirements and identifying quality needs, product improvements and customer requirements

• Drive and Support new product development and sustaining activities in supplier management ensuring supplier compliance and capability for Qualification, Approval, and Sustaining activities. Ensures adequate design control documentation and records are maintained to support life cycle of design history

• Provide quality support for Supplier Qualification and Approval steps and are completed adequately including areas in supplier selection, quality planning, risk analysis, critical to quality characteristics, supplier specification and DFM reviews, validations, verifications, quality agreements, supplier history files and other activities as needed

• Lead Supplier Capability Assessments to ensure suppliers are fully capable in meeting BD’s requirements

• Evaluate supplier validations, qualification, and sustaining reports and data utilizing statistical analysis to ensure supplier will deliver an acceptable quality level during manufacturing with properly established product specifications and driving improvements

• Ensures that supplier specifications and appropriate work instructions are appropriately specified and established before communicating to the supplier

• Review and authorize Supplier Process Changes following established guidelines and ensuring Quality approval for changes to product and/or device design specifications including process/material changes and manufacturing plant relocations. Review shall also consist of risk to end product, end product performance specifications, test methods, acceptance criteria, and release

• Review and support product and/or device shipping studies by providing quality and regulatory requirements, approving protocols, assessing generated data and approving final reports

• Provide support for Product and/or Device transfer, Scale-Up, and Process Validation at either Supplier or BD site

• Lead or participate in Supplier Risk Management activities appropriate to the initiative or situation

• Monitor quality data from Supplier Process reporting, BD QN / Nonconformance reports (Incoming/In process/Field), Service reports and Quality Alerts. Identifies, investigates, troubleshoots and resolves identified quality issues independently or by working with Manufacturing, Procurement, Service, Engineering, and Regulatory

• Initiate Corrective and Preventative Action plans and perform efficacy follow up

• Lead and conduct supplier quality system audits ensuring suppliers meet BD and regulatory requirements

• Responsible for developing Quality Plans, Production Part Approval requirements, Statistical based Inspection Plans and First Article Requirements for new supplier and/or materials

• Lead Design of Experiments, Statistical/Data Analysis, and MSA/Correlation studies

• Support Regulatory Affairs, as appropriate, by providing input for submissions or response to agency queries

• Support regulatory inspections at Supplier Sites

Primary Work Location

SGP Tuas - Tuas Plant

Additional Locations

Work Shift

SG Normal Office 0745-1645 (Singapore)

BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.