Quality Engineer I - Drive Quality & Continuous Improvement

7330 Bard Sendirian Berhad (150766-D); Kulim; On-site; MYR 60,000 - 90,000; Full time

Job summary

BD in Kedah (Kulim) Malaysia is seeking a Quality professional to support new product introductions and ongoing production by creating and maintaining quality plans, validating protocols, and approving inspection methods.

You will investigate customer complaints, perform root cause analysis, develop corrective actions, conduct training on Product and Quality Requirements, and help audits as part of the BD Excellence program.

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.

Job description

BD in Kedah (Kulim) Malaysia is seeking a Quality professional to support new product introductions and ongoing production by creating and maintaining quality plans, validating protocols, and approving inspection methods.

You will investigate customer complaints, perform root cause analysis, develop corrective actions, conduct training on Product and Quality Requirements, and help audits as part of the BD Excellence program.