QA Technical Specialist

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

BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. BD leads in patient and health care worker safety and the technologies that enable medical research and clinical laboratories. The company provides innovative solutions that help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures and support the management of diabetes. The company partners with organizations around the world to address some of the most challenging global health issues. BD has more than 40,000 associates across 50 countries who work in close collaboration with customers and partners to help enhance outcomes, lower health care delivery costs, increase efficiencies, improve health care safety and expand access to health.

BD has state-of-the-art facilities around the globe that provide an environment that enables our highly talented workforce to be the best at their professions. We hire associates who have a passion and commitment to advancing the world of health. We are always seeking great people to join our company on its journey to greatness.