Quality Specialist

Becton Dickinson Sdn. Bhd.; Kulim; Sur place; MYR 60 000 - 90 000; Plein temps

Résumé du poste

Becton, Dickinson, and Company in Kedah, Malaysia, seeks a Validation Engineer to lead eDHR system validation across manufacturing. You will design and execute IQ/OQ/PQ protocols, ensure data integrity, and meet FDA 21 CFR Part 11, ISO 13485, and internal standards. You’ll collaborate with IT, OT, quality, and manufacturing teams and support audits.

The role emphasizes risk-based validation, documentation, and sustaining validated states during updates, while mentoring junior staff.

Qualifications

• Experience in developing and executing validation protocols for software and equipment.
• Strong understanding of CSV principles and risk-based validation.
• Ability to conduct performance testing and document results.
• Experience with regulatory standards and audits.
• Proven ability to maintain data integrity and traceability.
• Ability to author validation documentation such as protocols and reports.

Responsabilités

• Develop and execute validation protocols (IQ/OQ/PQ) for eDHR systems and related equipment.
• Ensure validation activities meet regulatory standards (FDA 21 CFR Part 11; ISO 13485).
• Conduct performance testing and document results to confirm system functionality.
• Collaborate with QA to align validation with quality goals and participate in audits.
• Validate real-time production data capture and ensure data integrity across lifecycle.
• Author and maintain validation documentation, including SOPs and reports.

Connaissances

Validation planning

IQ/OQ/PQ execution

CSV principles

Data integrity analysis

Regulatory compliance

Risk-based validation

Cross-functional collaboration

Formation

Bachelor’s degree in biomedical engineering/QA/Engineering/IT

Outils

Apriso MES

Description du poste

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 visithttps://bd.com/careers (opens in new window).

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.

Primary Work Location

MYS Kedah - Bard Kulim (Malaysia)