BD (Becton, Dickinson and Company) Senior/ Quality Engineer - Product & Process in Tuas, Singapore
Job Description Summary
The Quality Engineer - Product & Process reports to the Quality Manager for the responsible and accountable of quality engineering/ label control/ assurance elements and activities supporting Operations including supply supplier. Has the responsibility of developing test instrumentation and procedures to maintain comprehensive, cost-effective and progressive Quality Standards for all plant products.
Ensuring that Quality Master Data is available, accurate and meets compliance requirements. Has the responsibility to maintain Quality Notifications and Deviation in SAP.
The QE will initiate and drive partnership, and collaborate with stakeholders, customers, and suppliers to support and execute Operation, Quality, and Regulatory Key Business objectives and Strategies for the Manufacturing site. The QE will also work with key functional groups for problem solving to improve processes. Focus on Performance/Metrics data for and drive value add quality initiatives for continuous improvements.
The QE will also work with external Regulatory and Compliance agencies ensuring timely and accurate submissions to respective requirements.
The QE is the technical liaison for all quality related aspects of supplier management including supplier approvals, qualifications, assessments and SCAR/CI activities. In addition, the QE/SQE will partner with Operations, Design, and Procurement groups to execute and monitor Supplier Management processes and strategies, and drive partnership and collaboration with the supply base.
Responsible for driving and executing Quality Engineering Sustaining Activities including Process Monitoring/ Evaluations, CI Improvements, Metric Reporting, Data Analysis, Control Plans, and Change Control.
Identifies, investigates, troubleshoots and resolves identified quality issues independently or by working with Manufacturing, Procurement, Engineering, and Regulatory.
Support Product Transfers and Scale Up from Innovation sites ensuring a timely and successful launch meeting all requirements and responsible for the quality and regulatory element in the Product Transfer process.Shall be capable to comply and improve Product Transfer process and ensures the design is appropriately specified and established before transferring into manufacturing to avoid increased risk.Responsible for execution of Quality Plans for Inspections ensuring statistical based rationale and justification.
Develops test methodologies, designs test data forms and writes standard test methods in support of new product lines, product line specials or product line extensions.
Leads Supplier Capability Assessments ensuring suppliers are fully capable in meeting BD’s requirements. Provides quality support for Supplier Qualification and Approval Process and are completed adequately including areas in quality planning, risk assessments, critical to quality characteristics, supplier spec., validations, verifications, quality agreements and control plans.
Facilitates and partners with suppliers to develop strong business and quality relationships ensuring strong communication and collaboration. Responsible for Supplier Management Monitoring meeting Compliance requirements including QBRs, Quality Metrics, and Auditing.
Support Change Review Board process authorizing / approving all changes (including Supplier Process Changes) following established guidelines.Responsible for Quality approval for changes to product and/or device design specifications including process/ material changes and manufacturing plant relocations.Review shall also consist of risk to end product, end product performance specifications, test methods, Regulatory requirements, acceptance criteria, and release
Initiates changes to existing practice and procedures to support compliance requirements. Communicates the need for compliance to members to all functional areas. Brings regulatory compliance questions/issues to the attention of the next level of management.
Reviews and supports product and/or device shipping studies by providing quality and regulatory requirements, approving protocols, assessing generated data and approving final reports.
Leads cross functional teams for quality initiatives project for continuous improvements as per Quality tools such as Design of Experiments, Statistical/ Data Analysis, and MSA/ Correlation.
Ensures Quality Assurance and Regulatory Compliance Systems are aligned with BD, Regulatory and Industry standard requirements.Must ensure that these systems meet the Quality needs, product/ process improvements and customer requirements.
Responsible for supporting and closing of Quality Notification, Deviation and Customer Complaints in a timely manner ensuring regulatory requirements are met; to manages and Investigates non-conforming materials and products for root causes (to regulations or procedures) and improvement opportunities (to increase compliance, reduce costs, etc.). Provides proactive guidance and advice to ensure that new or changed systems meet procedural and regulatory requirements.
Executes, and monitors a risk based Corrective and Preventive Action system ensuring nonconformance are documented, investigated, and corrected or with correction actions to prevent recurrence.
Leads and Supports activities relating to Field Corrective Actions, Adverse Events, Situational Analysis when needed.
Set up and responsible for the quality inspection plan including adequate controls are adequate and supporting documentation are available.
Support and executes associate training for QSR training program when require and determining and developing the type of internal process training needs.
Lead or participate in Risk Management activities appropriate to the initiative or situation.
Support Regulatory Affairs, as appropriate, by providing input for submissions or response to agency queries.Ensures that required documents are filed with appropriate agencies. Examples include FDA registration, HSA registration, CE etc.
Monitor quality data from QN, Deviation and Customer Complaints process, Manufacturing reports and customer input. Identifies, investigates, troubleshoots and resolves identified quality issues independently or by working with Manufacturing, Engineering, R&D and/or Regulatory.
Lead the disposition of raw materials, in-process samples (where applicable) and final products regardless of product load demands. Lead the documentation of Rework and/ or Special Inspections where applicable.
Approves decisions regarding, release, retest and /or discrepancies of product based on accurate interpretation of test results and investigations (OOS) coupled with technical knowledge.
Support 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.
Perform routinely functions in the SAP System for regular maintenance of the QM module: prepare and submit for approval Master Data additions, corrections and changes, create/change inspection plans, create Certificate of Analysis (COA), verify negative inventories, correct all transactions, and perform posting changes.
Develops, implements and audits approval systems to assure necessary reviews are conducted on Business Unit and Corporate level prior to revisions and new label development.
Develops, implements, and audits Label Control systems and procedures that will assure that the production departments are supplied with current labeling material when required.
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
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.