BD (Becton, Dickinson and Company) Senior/ Quality Engineer - System in Tuas, Singapore
Job Description Summary
The Quality Engineer - Systems reports to the Quality Manager for the lead quality systems compliances such as: Change Control, Customer Complaint, Internal Audit, Document Control, Record Retention, Management Review and Quality Performance Metrics (trending of Quality Notification, Deviation / Waiver, CAPA, Customer Complaint).
In addition to manage the QMS/ GMP/ GDP training program and/ or FDA and other agency regulations and industry practices awareness program, coordinating and ensure closure of Quality Notification, Deviations, Customer Compliant, CAPA, Change Control, Management Review, lead the Internal Audits and maintain Change Control and Document Control system.
The position also is responsible for supporting Quality Engineer - Product and Process/ Validation to identify compliance issues related to product lines to assure compliance with ISO standards and relevant countries regulations such as US FDA, NMPA, ANVISA, PAL, IVDR and Company strategies.
Manages and maintains the QMS/ GMP/ GDP training program and/ or FDA and other agency regulations and industry practices awareness program.
On an as needed basis support in communications with customers on technical matters.
Participates in the development and review of Standard Manufacturing Procedures, Standard Operating Procedures and Standard Test Methodologies.
Performs activities related to the evaluation of Quality Data of finished products in order to assure compliance to test methods and product claims, quality trends and issues (for both internal and supplier related) are communicated to the plant's staff management.
Assures Quality Notification and Deviation for Quality issues are generated, investigated, completed and closed in SAP and in accordance to procedures.
Assures that monthly reports are issued, published and distributed to responsible personnel as well as management staff in a timely manner. Periodically reports regulatory risk assessment and corrective action progress to management to mitigate risks.
Assures that CAPA(s), Customer Compliant(s) and SCAR(s) are evaluated by appropriate functional group to investigate non-conforming materials, components and products for root causes and effective corrective action(s) were implemented.
Manages and maintains initiation, tracking, processing and control of CAPA and Customer Complaints in Trackwise and SCAR in SAP.
Manages and maintains an effective Quality Management System and Quality System Regulations (QSRs) to facilitate ease of product flow, retrieval of test data, and/or status of product lots to minimize Quality Notification, in meeting sales projections and reducing customer complaints.
Assists in the solution of technical and/or related problems by effectively interacting with other Managers/Facilitators.
Interacts with auditors in reference to compliance issues during internal or external inspections. Maintains an awareness of FDA, ISO/PAL/ANVISA regulations and other agency regulations and industry practices.
Manages and maintain Internal QA Auditing Program in Trackwise.
Responsible for the implementation of an approved auditing plan in accordance with QSR and ISO 13485 and/or similar regulations. Establishes audit corrective action teams as needed, and monitors and reports corrective action progress.
Supports Regulatory or outside agencies performing inspections based on FDA Quality System Regulations; Other contracted agencies, such as ISO13485 audits.
Manages and maintain Change Control System in iBPS.
Manages and maintains an accurate electronic and hardcopy Master Record filling system.
Manages and maintains Documentation Control System in SAP-EcoMS to comply with internal requirements and with regulations on security, retention, accessibility, etc.
Works in conjunction with IT and SAP Teams for the implementation of the Documentation Management System.Conducts structured training sessions on requirements for submitting documentation to be included in Device Master Record e.g. determining type classification of document, writing a document in the appropriate format, assigning document number, use of correct forms, forms submission.
Provides technical assistance on software associated with the Documentation Systems (e.g. MS Office (Word, Power Point, Excel, Windows and Vision), SAP, SAP-EcoMS, Trackwiase and/ or iBPS.
Manages and maintains raw material vendor/ supplies qualification/ audit programs and/or maintenance of SCAR in Trackwise.
Assists in the preparation of presentations for Management Review and Metrics Maintenance/ Reporting
Support and assist on Validation Program, such as the assembly of validation packages and project protocols.
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
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.