Quality Engineer

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

Job summary

BD in Malaysia is seeking a Quality Assurance professional to support new product introductions and ongoing production by developing quality plans, validation protocols, and inspection methods, while driving root cause investigations and corrective actions.

You will monitor material nonconformances, lead audits, participate in continuous improvement, and help ensure compliance with local quality policies and regulatory requirements, including change control and risk management, within a

Qualifications

• A bachelor’s degree or equivalent (required).
• Experience in medical devices or pharmaceutical industries preferred; specify product classification if possible.
• Proficiency in root cause analysis tools.
• Knowledge of statistical techniques.

Responsibilities

• Support the development and maintenance of quality plans, validation plans, and protocols for new and existing products.
• Investigate customer complaints, identify root causes, and implement corrective actions.
• Analyze inspection, process, and product data to identify problems and opportunities for improvement.
• Lead or assist in change control and risk management processes; support audits and regulatory compliance.
• Coordinate with cross-functional teams and ensure compliance with BD quality policies and safety regulations.

Skills

Project QA

Bilingual EN/MY

Analytical thinking

Team player

Data interpretation

Deadline-driven

Education

Bachelor’s degree or equivalent

Medical device/pharma industry experience (preferred)

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

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.