Quality Engineer

BD; Kulim; On-site; MYR 60,000 - 100,000; Full time

Job summary

BD Kedah in Kulim, Malaysia is seeking a Quality Assurance professional to support new product introductions and the ongoing production lifecycle. The role emphasizes quality planning, validation, and data-driven improvements across manufacturing processes.

The candidate should have a bachelor’s degree with experience in medical devices or pharma, and be fluent in Bahasa Malaysia and English, able to work in a cross-functional team to ensure compliance and customer satisfaction.

Qualifications

• Bachelor’s degree or equivalent experience in medical device or pharmaceutical industry preferred.
• Experience with root cause analysis tools and statistical techniques.

Responsibilities

• Develop and maintain quality plans for new products and ongoing production.
• Approve validation plans and protocols, inspection methods and work instructions.
• Investigate customer complaints, identify root causes and corrective actions.
• Analyze inspection, process and product data to prevent quality problems and drive improvements.
• Lead change control and risk management processes and support audits.

Skills

Bahasa Malaysia

English

Education

Bachelor's degree

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.

Primary Work Location

MYS Kedah - Bard Kulim (Malaysia)