Quality Engineer

Hochuen Medical Sdn Bhd; Kulai; On-site; MYR 70,000 - 90,000; Full time

Job summary

A leading medical devices manufacturer in Malaysia is seeking a Quality Engineer to ensure the highest standards of quality and compliance for medical products. The ideal candidate will have a Bachelor's degree in Engineering or Quality Management and at least 5 years of experience in quality assurance within the medical device or pharmaceutical industry. Responsibilities include managing quality feedback, preparing reports, and leading corrective actions. The company offers competitive salary, bonuses, and opportunities for professional development.

Benefits

Competitive salary

Performance-based bonuses

Comprehensive health and life insurance

Generous paid time off

Professional development opportunities

Qualifications

• 5+ years of experience in quality engineering or assurance in medical device/pharmaceutical industry.
• Proven track record of implementing quality control systems.
• Strong knowledge of quality standards (ISO 13485, GMP).

Responsibilities

• Ensure product quality meets specifications.
• Prepare quality reports for management.
• Coordinate and manage quality feedback and issues.

Skills

Problem-solving

Analytical skills

SPC

FMEA

Six Sigma

Data analysis

Interpersonal skills

Education

Bachelor's degree in Engineering or Quality Management

Job description

As a Quality Engineer at Hochuen Medical Sdn Bhd, you will play a crucial role in ensuring the highest standards of quality and compliance for our medical products. Reporting to the Quality Assurance Manager, you will be responsible for implementing and maintaining robust quality control processes across our manufacturing facilities in Senai, Johor. This full‑time position is an excellent opportunity for an experienced quality professional to make a direct impact on the success of our growing company.

What you’ll be doing

Ensure quality of product meet customer specification and fitness for use

Prepare relevant quality report for management review

Responsible for customer's quality feedback and timely response as well as new/revised requirement

Work with production / sales department on quality issues and customer feedback.

Process SPC monitor and continual improvement to meet customer needs and satisfaction

Coordinate, lead and guide the matter of process discrepancy and product non‑conformity

Manage all quality-related issues within the manufacturing team (e.g. internal, supplier, customer and customer warranty)

To identify root cause and instigate permanent corrective actions (8D) for product quality issues.

To resolve all quality issues or irregular problem feedback by QA Inspectors/Production Operators

Continues work with supplier to improve process control to meet internal and customer requirements

Able to prepare relative product’s SIP or MSOP and training QC for SIP or MSOP

Perform any other task as assigned by superior

What we’re looking for

Bachelor's degree in Engineering, Quality Management or a related technical discipline

Minimum 5 years of experience in a quality engineering or quality assurance role, preferably in the medical device or pharmaceutical manufacturing industry

Proven track record of implementing and optimising quality control systems and processes

Excellent problem‑solving, analytical and decision‑making skills

Strong technical knowledge of quality management tools and methodologies (e.g. SPC, FMEA, Six Sigma)

Proficient in data analysis and reporting using relevant software tools

Excellent communication and interpersonal skills to collaborate effectively with cross‑functional teams

Knowledge of relevant quality standards and regulations (e.g. ISO 13485, GMP)

What we offer

Competitive salary and performance‑based bonuses

Comprehensive health and life insurance coverage

Generous paid time off and flexible work arrangements

Opportunities for professional development and career advancement

Supportive and collaborative work environment

About us

Hochuen Medical Sdn Bhd is a leading manufacturer of high‑quality medical devices, serving healthcare providers and patients worldwide. With a strong focus on innovation and quality, we are committed to improving patient outcomes and enhancing the delivery of healthcare services. Our state‑of‑the‑art production facilities in Senai, Johor are equipped with the latest technology and staffed by a dedicated team of professionals. We foster a culture of continuous improvement, collaboration and employee well‑being, making Hochuen Medical an excellent place to build a rewarding career.

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