Quality Engineer

Job Description Summary

**Job Description**:
We are the makers of possible

BD is one of the largest global medical technology companies in the world.
_Advancing the world of health_ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Why Join Us?

A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.

Become a maker of possible with us

Job Description Summary

You will support the QMS/ GMP/ GDP training program and/ or FDA and other agency regulations and industry practices awareness program, coordinating and ensure closure of Customer Complaint, CAPA, Change Control, Management Review, lead the Internal Audits and maintain Document Control system.

**Responsibilities**:

- Supports the maintenance of QMS for conformance to requirements and Company policies and documents these systems in the QA Policies / Procedures Manual.
- Coordinate with Technical Support at Business Unit any SAP System issue that impact the daily operations and assist in the promptly resolution.
- Assures receival, distribution to QC Labs of returned goods for customer complaint testing.
- Monitoring of complaints Queries and develop monthly reports to the Quality Manager / Quality Engineer(s).
- Assist in the coordination of meeting with other relevant Process Owners to discuss Customer Complaints / CAPA.
- Administrates the Change Control system and ensure it is updated.
- Develop and publish monthly reports of open Change Control.
- Monitoring and track the Quality Notification / Deviation to ensure update and closure by actions owner(s).
- Develop and publish monthly reports of open Quality Notification / Deviations.
- Administrates the Document Control system and ensure it is updated.
- Coordinates the QMS / GMP / GDP training program and/ or awareness of FDA and other agency regulations and industry practices for new hired employees and annual refresher.
- Coordinates internal audits and external audits.
- Assists in the preparation of presentations for Management Review and Metrics Maintenance/ Reporting.
- Maintains Quality Master Data in SAP System.
- Maintains an accurate electronic and hardcopy Master Record filling system.
- Maintains Documentation Control System on Network to comply with internal requirements and with regulations on security, retention, accessibility, etc.
- In conjunction with Quality Engineer - Systems provides technical assistance on software associated with the SAP, SAP-EcoMS, Trackwise and/or PEGA.
- 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.

Preferred Requirements
- Minimum 1 year experience in an industrial QA environment (such as Validation, QMS, Doc Control, Complaint handling and Change Control handling) in Medical Devices, Pharmaceutical or Life Science industry.
- Knowledge and experience in SAP, Excel, Word, and Quality Systems Software (e.g. Trackwise).
- Working knowledge of current QSR's, ISO, and ANVISA standards is an advantage.
- Effective interpersonal and problem-solving skills.

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

To learn more about BD visit:
Primary Work Location

SGP Tuas - Tuas Plant

Additional Locations

Work Shift

SG Normal Office 0745-1645 (Singapore)