Quality Specialist

BD Mexico; Kulim; On-site; MYR 120,000 - 180,000; Full time

Job summary

Becton, Dickinson and Company (BD) is hiring for a Validation specialist in Malaysia (Kulim). You will plan and execute validation activities for eDHR systems, ensuring compliance with FDA 21 CFR Part 11, ISO 13485, and CSV principles.

You will work with IT, OT, manufacturing, and QA to maintain validated states during changes and to document results. Ideal candidates have hands-on validation experience in digital manufacturing, MES (Apriso), and a strong data integrity mindset.

Qualifications

• Bachelor’s degree in biomedical engineering, QA, engineering or IT.
• Hands-on experience with eDHR systems, MES platforms (Apriso) and digital manufacturing.
• Experience developing and executing IQ/OQ/PQ validation for software and equipment.
• Strong understanding of CSV principles and risk-based validation.
• Skilled in testing, data analysis, and reporting for compliance.
• Proven ability to ensure regulatory compliance and quality standards.
• Knowledge of data integrity, traceability, and validation documentation.
• Ability to analyze test data, identify anomalies, and meet specs.
• Experience preparing regulatory submission documents and internal reports.
• Cross-functional collaboration with IT, OT, Manufacturing, Quality; change control.

Responsibilities

• Validation Planning & Execution for eDHR systems and related equipment.
• Ensure validation activities meet FDA 21 CFR Part 11 and ISO 13485.
• Conduct performance testing and document results to confirm reliability.
• System Compliance & Quality Assurance with internal and external standards.
• Process & Data Integrity: validate real-time production data capture and traceability.
• Documentation & Reporting: author protocols, reports, SOPs, analyze data.
• Cross-Functional Collaboration with IT, OT, manufacturing, and QA teams.

Education

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

Tools

Apriso MES

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.

Primary Work Location

MYS Kedah - Bard Kulim (Malaysia)

Work Shift

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.