Job Description Summary

Manages the Quality function in assigned manufacturing unit(s) by developing and maintaining quality control plans, monitoring non-conforming material, investigating customer complaints, and providing quality metrics to Manufacturing and Quality management. Assures t he manufacturing unit(s) is compliant to required procedures and regulations. Works cross -functionally to support and deliver continuous improvement activities and manufacturing unit objectives.

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:
Quality Engineer I
 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:
 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.

Required Skills

Optional Skills

.

Primary Work Location

MYS Kedah - Bard Kulim (Malaysia)

Additional Locations

Work Shift

MY3 Normal 8a-4.45p Group 26 (Malaysia)