Quality Engineer 1

BD Malaysia; Kulim; On-site; MYR 100,000 - 150,000; Full time

Job summary

A leading global healthcare company in Kedah, Malaysia is seeking a qualified Quality Assurance Engineer. Responsibilities include managing quality control functions, performing process validation, and leading quality improvement initiatives. Candidates should possess a Bachelor of Science degree and have 3-5 years of experience in manufacturing environments. Familiarity with Lean, Six Sigma, and quality engineering tools is advantageous. Join our team to ensure the highest quality standards are met in production processes.

Qualifications

• Minimum 3-5 years of experience in a manufacturing environment.
• Knowledgeable in Lean and Six Sigma methodologies.
• Exposure to quality engineering tools and techniques.

Responsibilities

• Perform process validation work and execute the protocol.
• Lead quality improvement activities and design investigation programmes.
• Analyze results and resolve quality problems.

Skills

Process validation

Quality Control evaluation

Lean

Six Sigma

SPC

QC tools

Data analysis

Education

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

Certificate in Quality Engineering

Tools

Minitab

DOE

ANOVA

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.

ESSENTIAL DUTIES AND 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.

EDUCATION & QUALIFICATION

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.

Minimum 3 – 5 years experience in a manufacturing environment on Production, QualityAssurance 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)

Work Shift

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

P2-14234