Quality Engineer

Becton Dickinson; Kulim; On-site; MYR 60,000 - 120,000; Full time

Job summary

BD is seeking a Quality Assurance professional to support new product launches and ongoing production in Kulim, Malaysia. You will develop quality plans, validation protocols and inspection methods, and lead investigations into customer complaints.

The role requires fluency in Bahasa Malaysia and English, and experience in the medical device field. You will contribute to continuous improvement and regulatory compliance while collaborating across teams.

Qualifications

• Experience in the medical device or pharmaceutical industry.
• Practice in the use of root cause analysis tools.
• Application of statistical techniques.

Responsibilities

• Support the implementation of new products and ongoing production by developing and maintaining quality plans, validation plans, inspection methods and work instructions.
• Investigate, document, perform root cause analysis and implement corrective actions for customer complaints.
• Compile, analyze and interpret inspection, process and product data to identify quality problems and continuous improvement opportunities.
• Lead change control and risk management processes; participate in internal and supplier audits as needed.
• Communicate across functions/departments and support regulatory and customer audits.

Skills

Root cause analysis

Analytical thinking

Teamwork

Education

Bachelor's degree or equivalent

Job description

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 Responsibilities

• 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.

Work Location

Primary Work Location MYS Kedah - Bard Kulim (Malaysia)

Additional Locations Work Shift BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.