Quality Specialist

Becton Dickinson; Kulim; On-site; MYR 134,000 - 190,000; Full time

Job summary

Becton Dickinson is seeking a Validation & Compliance professional in Malaysia to develop and execute validation plans for eDHR systems, ensuring compliance with regulatory standards such as FDA 21 CFR Part 11 and ISO 13485. You will coordinate with IT, OT, manufacturing, and QA teams to maintain validated states during system updates.

The role emphasizes data integrity, accurate real-time data capture, and thorough documentation for regulatory submissions.

Qualifications

• Bachelor's degree or equivalent in a relevant field plus hands-on validation experience.
• Experience developing and executing validation protocols for software systems and equipment.
• Strong understanding of computer system validation (CSV) principles and risk-based validation approaches.
• Knowledge of data integrity, traceability, and regulatory alignment in manufacturing environments.

Responsibilities

• Develop and execute validation protocols (IQ/OQ/PQ) for eDHR systems and related equipment.
• Ensure validation activities meet regulatory standards such as FDA 21 CFR Part 11 and ISO 13485.
• Collaborate with Quality Assurance to align validation with broader quality goals.
• Validate that production data is captured and stored accurately in real-time with traceability.
• Author and maintain validation documentation, including protocols, reports, and SOPs.
• Participate in audits and provide documentation to support compliance.

Skills

eDHR systems

MES platforms (Apriso)

validation protocols (IQ/OQ/PQ)

CSV validation principles

data integrity

regulatory compliance

data analysis & reporting

cross-functional collaboration

Education

Bachelor's degree in biomedical engineering, Quality Assurance, Engineering, or Information Technology

Tools

Apriso

Job description

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.

Job Description Validation Planning & Execution

Develop and execute validation protocols (IQ/OQ/PQ) for eDHR systems and related equipment. Ensure validation activities meet regulatory standards such as FDA 21 CFR Part 11 and ISO 13485. Conduct performance testing and document results to confirm system functionality and reliability.

System Compliance & Quality Assurance

Ensure eDHR systems comply with internal quality standards and external regulations. Collaborate with Quality Assurance teams to align validation efforts with broader quality goals. Participate in audits and provide documentation to support compliance.

Process & Data Integrity

Validate that eDHR systems accurately capture and store production data in real-time. Monitor data integrity across the manufacturing lifecycle-from raw materials to finished goods. Ensure traceability and error-proofing mechanisms are functioning as intended.

Documentation & Reporting

Author and maintain validation documentation, including protocols, reports, and SOPs. Record and analyze test data to identify anomalies and ensure systems meet specifications. Prepare detailed reports for internal review and regulatory submissions.

Cross-Functional Collaboration

Work with IT, OT, manufacturing, and quality teams to coordinate validation activities. Support changing control processes and ensure validated state is maintained during updates. Train and mentor team members on validation procedures and compliance requirements.

Qualifications

• Bachelor’s degree in biomedical engineering, Quality Assurance, Engineering, or Information Technology.
• Hands-on experience with eDHR systems, MES platforms (preferably Apriso), and digital manufacturing environments.
• Experience developing and executing validation protocols (IQ/OQ/PQ) for software systems and equipment.
• Strong understanding of computer system validation (CSV) principles and risk-based validation approaches.
• Skilled in performance testing, data analysis, and reporting to confirm system reliability and compliance.
• Proven ability to ensure system compliance with internal quality standards and external regulatory requirements.
• Knowledge of data integrity, error-proofing, and traceability mechanisms in manufacturing systems.
• Proficient in authoring and maintaining validation documentation, including protocols, SOPs, and test reports.
• Ability to analyze test data, identify anomalies, and ensure systems meet defined specifications.
• Experience preparing regulatory submission documents and internal review reports.

Cross-Functional Collaboration

Collaboration skills to work with IT, OT, Manufacturing, and Quality teams. Experience supporting change control processes and maintaining validated states during system updates.

Why Join Us?

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.

Required Skills

Optional Skills . Primary Work Location MYS Kedah - Bard Kulim (Malaysia) Additional Locations Work Shift 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.