QA Technical Specialist

BECTON DICKINSON MEDICAL PRODUCTS PTE LTD; Singapore; On-site; SGD 70,000 - 110,000; Full time

Job summary

BD Medical Singapore seeks a Technical Leader to guide auditor resources, ensure regulatory compliance, and coach teams in quality activities. You will drive root-cause investigations and CAPA follow-ups while coordinating cross-functional efforts and training plans.

Role focuses on SOP/WI development, measurement systems, and participation in quality assurance committees. Diploma holders with GMP knowledge are preferred.

Qualifications

• Experience applying statistical methods to quality data.
• Understanding of product quality requirements and GMP basics.
• Competency assessment aligned to work tasks.

Responsibilities

• Lead in managing auditor resources to support quality function activities and ensure regulatory compliance.
• Maintain root cause analysis and corrective/preventive actions for non-conformances.
• Develop and execute skill matrices and training plans.
• Coordinate cross-functional and external vendor activities for quality projects.
• File and maintain quality records for traceability and audits.
• Participate in kaizen, safety, and continuous improvement initiatives.

Skills

Statistical techniques

Product quality knowledge

Competency assessment

Education

Diploma in Engineering

Job description

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.

WHAT YOU WILL DO:

• Write & Update Standard Operating Procedure, Standard Work Instruction and On the Job Training documentation.
• Conduct investigation and write reports on root cause and evaluate corrective and preventive actions
• Develop & Execute Skill Matrix, and Training plan.
• Manage resources availability to meet production and project prioritizations.
• Manage AMS, C2C training and Conflict / Grievance.
• Block stock containment verification, unblock stock, check for QN Completeness, CAPA follow up & effectiveness monitoring, complaint samples failure analysis.
• Ensure all inspection forms and other quality records are filed and maintained for lot traceability and record retention purpose, in the respective lot master.
• Develop measurement system including programming, jig design, training, MSA. Ensure alignment to test method and manufacturing specifications.
• Develop Defect Album, Create Limit Samples, and Perform Measurement Equipment Troubleshooting.
• Participate projects Eg. Minitab Analysis, Rationale sampling support.
• Coordinate activities with cross departmental & external vendor.
• Participate and lead the pre-assigned committees in Quality Assurance Department.

Supporting Tasks

• Contribute into departments activities that are needed in order to achieve goals set for the department e.g., Kaizen submission, team building, safety kaizen submission, 20Keys and others.
• Participate in the discussion and review of team's performance in the daily shift changeover meeting.
• Participate in continuous improvement initiative / activities.
• Perform any other tasks as assigned.

General Accountability

• Observe BD Code of Ethics
• Apply SOP and/or SWI in daily operations.
• Good Manufacturing Practice (GMP) accountability, observing GMP rules and procedures.
• Reporting up on all quality and non-quality related incidents / accidents, near misses, non-conformance with SOP or specifications, deviations from plan, and when required, to take part in further investigations.

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.

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.

JOB REQUIREMENTS

• Minimum Diploma in Engineering.
• Competency Assessment in accordance to work task assigned
• Knowledge of statistical techniques
• Product quality knowledge