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Working at BD

  • Company employees
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Office locations

Join BD as a Quality Engineer in Kulim, Malaysia. In this full-time role, you will support new and existing product manufacturing by developing quality plans, driving root cause investigations, ensuring regulatory compliance, and leading continuous improvement projects.

Requirements

  • Minimum of a bachelor's degree or equivalent experience is required.
  • Experience in project QA and application of statistical techniques.
  • Practice in the use of root cause analysis tools.
  • Fluency in Bahasa Malaysia and English (written and oral).
  • Preferred: Experience in the medical device or pharmaceutical industry.

Skills & Responsibilities

  • Root cause analysis: Investigate customer complaints and material nonconformances to identify issues and implement corrective actions.
  • Statistical analysis: Compile and interpret inspection and process data to prevent quality problems and drive continuous improvement.
  • Quality planning: Develop quality plans, approve validation protocols, and establish inspection methods and work instructions.
  • Audit and compliance: Facilitate change control, risk management, and participate in internal, supplier, and regulatory audits.
  • Potential transition routes: People from manufacturing engineer or quality control inspector roles may bring production and inspection skills, alongside meeting the required analytical and communication capabilities.

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

Job Responsibilities: (Primary Duties, Roles, and/or Authorities)
 Support the implementation of new products and ongoing production of existing products, processes,
and changes by developing and maintaining quality plans, approval of validation plans and protocols,
inspection methods, and work instructions.
 Responsible for the investigation, documentation, root cause, and identification of corrective action
activities of customer complaints.
 Compile, analyze and interpret inspection, process, and product data to identify and prevent quality
problems and identify continuous improvement opportunities.
 Responsible for rework instructions (including verification or validation of instructions) and may assist
in rework training.
 Conduct training regarding Product and Quality Requirements.
 Monitor material nonconformances including aging and is a member of the cross-functional
investigation, root cause, and corrective action team to resolve material nonconformances.
 Support manufacturing and quality process continuous improvement projects.
 Facilitate appropriate and compliant use of change control and risk management processes.
 Communicate across functions/departments.
 Develop working knowledge of applicable regulatory, Corporate and/or Business Unit requirements.
 Lead implementation of the Quality Component of the BD Excellence operating system including
create/maintain the Quality Loss Landscape.
 Assists in regulatory and customer audits as needed. May conduct internal and supplier audits.
 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.
 Possibly supervise Quality Specialist and Quality Inspector.
 Other duties as assigned.

Education and Experience:
 A minimum of a bachelor’s degree or equivalent experience for
 Experienced in the medical device or pharmaceutical industry, add specific product classification or
type such as disposable, software, etc. (Preferred)
 Practice in the use of root cause analysis tools
 Application of statistical techniques

Knowledge and Skills:
 Experience in project QA.
 Must be able to communicate fluently (written and oral) in Bahasa Malaysia and English.
 Must be systematic and analytical.
 Good motivational skill and has ability to work as a team.
 People-oriented personality.
 Ability to analyze and interpreted data.
 Deadline-oriented; able to maintain a high activity level and to effectively manage and prioritize tasks
and responsibilities.

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

Apply now
BD

Quality Engineer

Kulim
On-site

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