Quality Engineer 1

Becton Dickinson Sdn. Bhd.; Kulim; On-site; MYR 45,000 - 65,000; Full time

Job summary

A leading medical technology company is seeking a Quality Assurance Engineer in Kulim, Malaysia. The role involves overseeing quality control functions, leading validation processes, and ensuring compliance with regulatory standards. Candidates must have a Bachelor's degree in relevant fields and 3-5 years of experience in manufacturing. Knowledge of Lean, Six Sigma, and Quality Engineering tools is preferred. This position offers a comprehensive scope of responsibilities and opportunities for continuous improvement in quality initiatives.

Qualifications

• Minimum 3-5 years experience in a manufacturing environment.
• Exposure to Quality Engineering tools, e.g., SPC, QC tools.

Responsibilities

• Lead quality control function and QA activities.
• Perform process validation work and data analysis.
• Participate in quality improvement activities.

Skills

Process validation

Quality improvement

Data analysis

Lean methodology

Six Sigma

Education

Bachelor of Science in Manufacturing/Engineering/Mathematics/Applied Science

Certificate in Quality Engineering

Tools

Minitab

SPC

QC tools

Job description

Job Description Summary

Report to the Quality Senior Manager. Responsible for all in-process quality control function and QA activities for Dipping, First Inspection, Finishing, Packaging, Cartoning, Label Printing, Lot Release and Purewick. Plan, organize, coordinates and lead projects relating to process, manufacturing and quality to support the requirements of the Quality Assurance System. Provide leadership in the analysis and resolution of manufacturing quality problem using specific techniques and tools. Evaluate the state of manufacturing processes to ensure adequate control and continuous improvement. Assist the Quality Senior Manager in monitoring Quality Audit activities and attending to external audits.

Responsibilities

• Perform process validation work, including packaging validation by writing protocol, executing the protocol, performing data analysis and writing report.
• Participate or lead quality improvement activities pertaining to adverse quality trend or customer complaints.
• Design investigation programmes and engineering experiments to determine sources of product nonconformance.
• Analyze results and recommend action.
• Perform continuous Quality Control evaluation and trend analysis on product quality issues, resolve quality problems and initiate corrective action with other departments as required.
• Responsible for the issuance of product item number and bill of material for Finished products.
• Review and comment the validation protocols & report issued by other departments.
• Effectively communicate product quality requirement based on audits and trends to production and process personnel.
• Perform formal release of finished product which complies with the company’s specified standards, the AS/NZS2696, the European Standard EN 1616, ASTM F-623 or any other relevant regulatory standards.
• Be a QA Representative in Non Design and Design Change Projects.
• Carry out administrative duties and special projects related to QA activities as instructed by direct superior.
• Prepare and adhere to the annual budget for department 7865.
• Be a QA representative who participate in R&D Transfer Project and Plant to Plant Transfer Project.
• Assist Quality Manager/Unit Manager/Quality Senior Manager in carrying out any special project or assignment.

Qualifications

Education: Bachelor of Science in Manufacturing/Engineering/Mathematics/Applied Science. Certificate in Quality Engineering will be an advantage. Knowledgeable in Lean and Six Sigma will be an advantage.

Experience: Minimum 3 – 5 years experience in a manufacturing environment on Production, Quality Assurance or Manufacturing Engineering. Exposed to Quality Engineering tools and techniques, e.g. SPC, QC tools DOE, ANOVA and Minitab.

Primary Work Location

MYS Kedah - Bard Kulim (Malaysia)

Additional Locations

No additional locations.

Work Shift

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