BD (Becton, Dickinson and Company) QA Technical Specialist (Technical Leader) in Tuas, Singapore
Job Description Summary
Generally, Technical Specialist provide technical expertise to support quality functions in leading daily operations, managing preventive maintenance, project execution, accountability on quality assurance activities and the overall auditor resource management in quality function.
The primary role of Technical Leader is to take lead in managing auditor resources to support quality function activities and meet targeted indicators. They are expected to work with Cross functional Team to ensure compliance to Regulatory and Quality requirements. This role also facilitates meetings with various Engineers or Subject Matter Experts to determine the root course of non-conformance materials and to ensure compliance to Regulatory and Quality requirements.
The secondary role of Technical Leader is to provide technical expertise and coaching or training where applicable.
A. General Accountability
A1. Safety and ISO14001 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.
A2. 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.
A3. Good Manufacturing Practice (GMP) accountability. Observing GMP rules and procedures.
A4. Apply SOP and/or SWI in daily operations.
A5. Observe BD Code of Ethics
A6. Reporting up on all incidents / accidents, near misses, deviations from plan and when required, to take part in further investigations.
A7. Reporting up on all quality incidents, near misses, non conformance from SOP, Specifications and when required, to take part in further investigations.
B. Operation Tasks
B1. Write & Update Standard Operating Procedure, Standard Work Instruction and On the Job Training documentation.
B2. Develop & Execute Skill Matrix, and Training plan.
B3. Manage resources availability to meet production and project prioritizations.
B4. Manage AMS, C2C training and Conflict / Grievance.
B5. Block stock containment verification, unblock stock, check for QN Completeness, CAPA follow up & effectiveness monitoring, complaint samples failure analysis.
B6. Ensure all inspection forms and other quality records are filed and maintained for lot traceability and record retention purpose, in the respective lot master.
B7. Develop measurement system including programming, jig design, training, MSA. Ensure alignment to test method and manufacturing specifications.
B8. Develop Defect Album, Create Limit Samples, and Perform Measurement Equipment Troubleshooting.
B9. Participate projects Eg. Minitab Analysis, Rationale sampling support.
B10. Coordinate activities with cross departmental & external vendor.
B11. Participate and lead the pre-assigned committees in Quality Assurance Department.
C. Supporting Tasks
C1. Contribute into departments activities that are needed in order to achieve goals set for the department eg. Kaizen submission, team building, safety kaizen submission, 20Keys and others.
C2. Participate in the discussion and review of team's performance in the daily shift changeover meeting.
C3. Participate in continuous improvement initiative / activities.
C4. Perform any other tasks as assigned.
2 . Knowledge & Experience
A. Preferably Diploma in Engineering field.
B. Competency Assessment in accordance to work task assigned.
C. Knowledge of statistical techniques.
Primary Work Location
SGP Tuas - Tuas Plant
SG Normal Production 0700-1600 (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.