Quality Engineer 1

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

Job summary

A leading medical technology firm in Kulim, Malaysia, is looking for a Quality Assurance Specialist to ensure compliance with quality standards and manage customer complaints. The ideal candidate has a bachelor’s degree, strong skills in quality engineering, and experience in the pharmaceutical industry. This role requires fluency in Bahasa Malaysia and English, as well as proficiency in MS Excel. Join us to support our commitment to quality and excellence.

Qualifications

• Minimum of a bachelor’s degree or equivalent experience.
• Experienced in the medical device or pharmaceutical industry is an advantage.
• Knowledge of Lean and Six Sigma is beneficial.

Responsibilities

• Lead investigations into customer complaints.
• Develop corrective and preventive action plans.
• Monitor effectiveness of complaint handling processes.

Skills

Fluent in Bahasa Malaysia

Fluent in English

Strong analytical skills

Computer literate

Team spirit

Ability to meet deadlines

Education

Bachelor's degree in relevant field

Certificate in Quality Engineering

Tools

MS Excel

Quality Engineering tools

Job description

Job Description Summary

Ensure the Quality System complies with the company’s Quality Assurance policies. Plan, organize, coordinate, and lead projects related to process, manufacturing, and quality to support the Quality Assurance System requirements. Assist the Quality Manager QMS with special assignments or tasks. Customer Complaint -Manage customer complaints in accordance with established procedures.

Job Description

P2-14200

Customer Complaint

• Lead investigations into customer complaints to identify root causes of quality issues.
• Collect and analyze data related to complaints to determine trends and recurring problems.
• Develop and implement corrective and preventive action plans to address customer complaints.
• Monitor the effectiveness of CAPA activities to ensure issues are resolved and do not recur.
• Provide timely and accurate updates to customers on the status of their complaints and resolutions.
• Maintain detailed records of customer complaints, investigations, and resolutions.
• Prepare reports on complaint trends and CAPA effectiveness for Management Review.
• Work closely with manufacturing, engineering, and quality teams to address and resolve customer complaints.
• Identify opportunities for process improvements based on customer feedback and complaint data.
• Support teams in understanding and adhering to quality standards and procedures.
• Ensure all complaint handling processes comply with industry standards, regulatory requirements, and company policies.
• Support manufacturing and quality process continuous improvement projects.
• Communicate across functions/departments.
• Support the BD Excellence operating system implementation.
• 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.

Other duties as assigned.

Education And Experience

• A minimum of a bachelor’s degree related field or equivalent experience.
• Experienced in the medical device or pharmaceutical industry will be an advantage.
• Basic knowledge on products manufactured at BD Kulim and BD Quality System.
• Certificate in Quality Engineering will be an advantage.
• Knowledgeable in Lean and Six Sigma will be an advantage.
• Industrial quality assurance experience in an asset though not a pre-requisite.
• Exposed to Quality Engineering tools and techniques, e.g. SPC, QC tools DOE, ANOVA and Minitab.
• Work is closely supervised, follows specific, detailed instructions.

Knowledge And Skills

• Must be able to communicate fluently in written and oral Bahasa Malaysia and English.
• Familiarity with standards such as ISO as well as regulations like FDA guidelines.
• Strong analytical skills to identify and resolve compliance issues.
• Able to meet tight deadlines.
• Computer literate, able to use advanced function of MS Excel.
• Team spirit is essential.
• Deadline-oriented; able to maintain a high activity level and to effectively manage.

Prioritize tasks and responsibilities.

Primary Work Location

MYS Kedah - Bard Kulim (Malaysia)

Work Shift

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