BD (Becton, Dickinson and Co.)
Quality Executive, SEA
🇲🇾Kuala Lumpur, Kuala Lumpur, Malaysia6 days ago
ExecutiveFull TimeEN
We are the people who give possibilities purpose
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.
Who We Are
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare sector. 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.
Job Summary
The Quality Executive, SEA will support the implementation and maintenance of Becton Dickinson's Quality Management System across the Southeast Asia region, ensuring compliance with relevant regulations, standards, and company policies. This role involves assisting with quality assurance activities, supporting internal and external audits, and contributing to continuous improvement initiatives.
Job Responsibilities
* Assist in the development, implementation, and maintenance of the Quality Management System (QMS) in accordance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory requirements for medical devices.
* Support regional quality assurance activities, including document control, change control, non-conformance management, CAPA (Corrective and Preventive Actions) processes, and complaint handling.
* Participate in internal and external audits (e.g., regulatory inspections, third-party audits, supplier audits) by preparing necessary documentation, assisting auditors, and supporting follow-up actions.
* Manage adverse event reporting to regulatory authorities in SEA in accordance with local reporting requirements and timelines.
* Coordinate and support Field Safety Corrective Actions (FSCA), including field safety notices, communication to stakeholders, tracking, and closure.
* Support the evaluation of post‑market surveillance data and ensure appropriate escalation, trending, and reporting in line with global and regional quality procedures.
* Act as a liaison between SEA markets and global quality teams to ensure consistent and compliant post‑market quality processes.
* Support the review and approval of quality-related documents, including procedures, work instructions, and records, to ensure accuracy and compliance.
* Assist in conducting quality training programs for employees across the SEA region to ensure understanding and adherence to quality requirements.
* Contribute to the investigation of quality issues, root cause analysis, and the implementation of effective corrective and preventive actions.
* Support the monitoring and reporting of key quality metrics to identify trends and drive continuous improvement initiatives.
* Collaborate with cross-functional teams, including Regulatory Affairs, Operations, and Commercial, to ensure alignment on quality objectives and processes.
* Stay updated on relevant regulatory changes and industry standards impacting medical device quality and communicate these effectively within the organization.
* Perform other quality-related duties as assigned by the Quality Management.
Job Qualifications
* Bachelor's degree in a relevant scientific or engineering discipline (e.g., Biomedical Engineering, Biotechnology, Chemistry, Pharmacy).
* Minimum of 2-4 years of experience in a Quality Assurance or Quality Control role within the medical device, pharmaceutical, or other regulated industries.
* Familiarity with Quality Management Systems (QMS) requirements, particularly ISO 13485 and/or FDA 21 CFR Part 820.
* Basic understanding of regulatory requirements for medical devices in Southeast Asia countries (e.g., HSA, MDA, TFDA, etc.) is a plus.
* Experience in post‑market quality activities such as adverse event reporting, vigilance, or FSCA coordination is an advantage.
* Experience with document control, non-conformance, CAPA, and change control processes.
* Strong analytical and problem-solving skills with attention to detail.
* Excellent written and verbal communication skills in English.
* Ability to work independently and as part of a team in a fast-paced environment.
* Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
* Willingness to travel occasionally within the SEA region if required.
Culture and Benefits
Here at BD, we embrace a growth mindset, building capabilities for the future and helping you become the best version of yourself. We offer our employees a clear direction and career pathway for development. We pride ourselves on our transparent and rigorous talent processes that are inclusive, deeply embedded in trust, aligned with our culture, and enable us to achieve strategic imperatives of the organization. Our leaders are committed, engaged and accountable to making talent our top priority.
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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
To learn more about BD visit https://bd.com/careers.
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.
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