Quality Engineer 1

Becton, Dickinson and Company; Kulim; Vor Ort; MYR 60.000 - 100.000; Vollzeit

Zusammenfassung

Becton, Dickinson and Company (BD) in Malaysia’s Kedah Kulim region is seeking a Quality/Regulatory professional to support new product implementation and ongoing production by maintaining quality plans, validating processes, and ensuring compliance with BD policies. The role involves investigations of customer complaints, root-cause analysis, and leading corrective actions within cross-functional teams.

The position focuses on sustaining BD Excellence quality systems, enabling change control,

Qualifikationen

• Develop and implement quality plans and validation protocols.
• Investigate customer complaints, identify root causes and implement corrective actions.
• Lead quality improvement initiatives and change-control processes.
• Assist internal and supplier audits as needed.
• Ensure compliance with BD quality policies and safety regulations.

Aufgaben

• Support manufacturing and quality process improvement projects.
• Provide training on Product and Quality Requirements.
• Monitor nonconformances and participate in cross-functional investigations.
• Communicate across functions and departments.
• Support regulatory audits and audits as needed.

Kenntnisse

Quality Assurance

Root Cause Analysis

CAPA

Change Control

Audits

Regulatory Knowledge

Data Analysis

Continuous Improvement

Tools

Excel

Jobbeschreibung

We are the people who give possibilities purposeBD 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 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.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 SkillsOptional Skills.Primary Work LocationMYS Kedah - Bard Kulim (Malaysia)Additional LocationsWork ShiftMY3 Normal 8a-4.45p Group 26 (Malaysia)