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

Responsible for overall management of Process Validation Program, Stability Program and PFMEA
program.
. Coordinate, monitor and execute the Process Validation Program and Stability Program for Bard Sdn.
Bhd. to ensure compliance to BD Corporate procedure, Division procedure and Bard Sdn. Bhd.
procedure.
. Be a validation independent reviewer and technical independent reviewer for process validation protocol
& report. Review process validation data generated and performed statistical analysis where
appropriate.
. Be a change control coordinator for the site change project.
. Perform gap analysis against the BD Corporate Procedure, Divisional Operating Procedures and
Corporate Policy and update local procedures accordingly.
. Maintain and update, when necessary, all BOPs for Process Validation, PFMEA, Software Val idation
Program, Finished Product Testing and Stability Program.
. Be the protocol originator for component qualification, ship testing, accelerated aging, real time stability
and packaging validation activities for the plant projects including supplier relocation, cost improvement,
localization, material change, quality improvement as assigned.
. Responsible for change supporting documents such as Stability Assessment, Packaging Assessment,
Component Qualification Strategy, Master Validation Plan etc.
. In-charge for the execution of accelerated aging study and yearly maintenance of stability chamber for
the study.
. Provide validation update on Post Market Surveillance (PMS) for all product family in BD Kulim.
. Assist the Quality Unit Manager in executing special project or assignment.
. Perform any other relevant and related responsibilities that may be assigned from time to time as required by the Management.

. Support manufacturing and quality process continuous improvement projects.
. Communicate across functions/departments.
. Support in implementation of the Quality Component of the BD Excellence operating system including
create/maintain the Quality Loss Landscape.
. Comply with all local BD quality policies, procedures, and practices through consistent application of
sound quality assurance principles.
. Comply with all local, state, federal, and BD Safety regulations, policies, and procedures including
RCRA Hazardous waste regulations.
. Other duties as assigned.

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 .

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

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Primary Work Location

MYS Kedah - Bard Kulim (Malaysia)

Additional Locations

Work Shift

MY3 Normal 8a-4.45p Group 26 (Malaysia)

Quality Engineer 1