BD (Becton, Dickinson and Company) Senior/ Quality Engineer - Laboratory in Tuas, Singapore
Job Description Summary
The Quality Engineer - Laboratory reports to the Quality Manager for the responsible and accountable for establishing and directing all laboratory activities for Label Control, Quality Testing of raw materials, WIP and finished products. Has the responsibility of developing test instrumentation and procedures to maintain comprehensive, cost-effective and progressive Quality Standards for all plant products.
This position lead a team of QA Technical Specialist to determine whether or not the raw materials, WIP and finished products conform to specifications and assure only release products that are safe, effective and perform as intended. Support OOS and customer complaint investigation.
This position is responsible for the Calibration and Preventive Maintenances program for the laboratory equipment.
To supervise a group of QA Technical Specialist or equivalent assures that the product/ raw materials testing conforms to established documented procedures and specifications regardless of product load demands.
Facilitates and coordinates the activities of Label Control System such as maintains an adequate label/literature inventory, maintains the file of Master Label Reference used in the company, as scheduled, release labeling materials to using departments, modifies label/ literature and initiates labeling changes for approval, as necessary.
Maintains an adequate technical staff by cross-training so as to support Business Unit Sales and meet department goals.Initiate formal personnel development program as necessary and controls absenteeism and employee turnover.
Assures Quality metrics are met and operates the department within operating budgets.
Lead the maintenance of effective and safe testing facilities and equipment.Assures GLPs and Housekeeping Standards are followed in all laboratory areas. Supports Production, Technical Service and Planning in meeting sales projections and reducing customer complaints.
Lead the maintenance of the equipment calibration and preventive maintenance program within the laboratory areas in compliance with QSR regulations. Assures that calibration and PM is performed as scheduled.
Lead the maintenance of stock cultures according to written/approved procedures.
Lead the maintenance of BD ASCP (Associate Sample Collection Program), the employee voluntary blood donation for prodcut testing.
Lead the stability and expiration date validation studies of products to establish, verify, decrease and/or extend expiration dates and storage conditions. Submits data to Management for proper action.
Periodically audits laboratory documentations: such as log sheets and test data sheets for accuracy, relevancy and uniformity. Initiates changes for documentation revisions, where applicable to facilitate more meaningful testing and/or optimized efficiency with possible cost reductions.
Develops, implements, and audits Label Control systems and procedures that will assure that the production departments are supplied with current labeling material when required.
Review of Batch History Records for verification and accountability of the lot and release if found acceptable. Initiates appropriate action if any discrepancy is noted.
Maintains the logging of the Documentation of Rework and Special Inspections.
Facilitates lean activities in the Laboratory, collaborates and participates in the plant programs/ initiatives to achieve company goals (ie. DMS, Six Sigma, Lean Manufacturing, Validation Tool Kit).
Support and/ or approve testing activities of finished products in order to assure compliance to Test Methods and product claims.
Support and/ or approve disposition of standard and special raw materials, in-process samples (where applicable) and final products.
Support and/ or approves decisions regarding release, retest and /or discrepancies of product based on accurate interpretation of test results and investigations (OOS) coupled with technical knowledge.
Plans, documents and participates in quality assurance and QSR/ISO training programs.
Implement new laboratory testing programs, which focus on instrumentation improved technology, cost reduction and rational sampling in support of new product lines, product line specials or product line extensions. Lead the special testing services program to Operations, QA and/ or R&D where required.
Assists in the following activities monitoring and training, accident investigation, waste handling, etc.
Assists in Internal QA Auditing Program, external regulatory and compliance audits/ inspections as required.
Assists in Validation Program which include Risk Analysis/ PFMEA, protocol development, execution, data analysis and report, as required.
Participates and contributes to continuous improvement activities. Keeps abreast of the basic requirements for compliance in own area of work and complies with those requirements, brings regulatory compliance questions/ issues to the attention of management.
Safety & ISO 14001 Environmental accountability: Ensure a safe, healthy and environmentally-friendly workplace by observing Company’s rules and procedures. Active involvement in prevention, elimination of potential safety hazards and participation in activities which promotes recycling, replacement and reduction of resource materials.
Safety & health accountability:Safety and health are important to BD and we encourage the observance of all safety programs and training assigned to you. Such programs are to be attended in a timely manner to ensure that work tasks carried out are in accordance to our safety guidelines and SOPs.
Performs other duties as requested by Facilitator.
Primary Work Location
SGP Tuas - Tuas Plant
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.