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.
**_KEY RESPONSIBILITIES_**
* 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
* Support activities relating to Field Corrective Actions, when needed
* Facilitate and Partner with suppliers to develop strong business and quality relationships ensuring strong communication and collaboration
* Establish new initiatives to support ongoing improvement of Supplier Quality Management Systems
**Education and Experience**
* Bachelor of Science Engineering Degree (e.g. Industrial, Mechanical, Electrical)
* At least 3 years of experience in Quality / Supplier Quality in a manufacturing environment working in a FDA or ISO regulated environment
* Six Sigma Green Belt and/or Certified (e.g. ASQ) Quality Engineer or equivalent (Prefer Six Sigma Black Belt Certified)
**Skills and Knowledge**
* Robust understanding of QSR, Design Control, ISO, Product Risk Management and GMPs as defined in CFR 820
* Excellent people interaction, team building, leadership, and communication skills including providing effective presentations.
* Strong background in Manufacturing processes including process development and optimization
* Experience in managing variety of commodities including Instrument Finished Goods CMs, PCBAs/ Electronics, Sheet metal, Machined Parts, Optics/Lasers, and Cabling harnesses
* Demonstrate Competency in Mechanical processes and Electro Mechanical Assemblies. Well versed in mechanical engineering analytical skills including metrology.
* Understanding of precision CNC machining and sheet metal fabrication processes and able to read and interpret engineering drawings and associated GD&T.;
* Proficient in project management, analytical, critical thinking, problem solving and prioritization skills
* Demonstrate innovative and implementation skills
* Demonstrate knowledge of Process Validation, Risk Analysis/FMEAs, and Production Part Approval Process (PPAP)
* Demonstrate knowledge of Statistics and Data Analysis to drive data based results and decisions.
* ISO 9000/13485 lead auditing experience
* Demonstrated competency in process analysis, problem solving skills, and improvement using process flow and Lean Manufacturing method
* Strong Troubleshooting skills at both process and product level
* Demonstrates high ethical and values that exemplifies BD’s Core Values and Principles
* Experience in SAP, Minitab, and Quality Systems Software (e.g. Trackwise)
* Must have capable innovative and implementation skills
*Job:* Quality
*Primary Location:* SG-Tuas
*Shift:* First Shift / Day Job
*Req ID:* QUA101HI