Quality Engineer

GN ReSound (Malaysia) Sdn Bhd; Kulai; On-site; MYR 67,000 - 100,000; Full time

Job summary

GN ReSound (Malaysia) Sdn Bhd in Kulai, Johor, seeks a Quality Engineer to drive quality management systems, inspect processes, and lead continuous improvement in manufacturing. You will handle complaints, validate processes, review batch records, and collaborate with cross-functional teams to contain issues and implement corrective actions.

The role requires a Bachelor or Diploma in Science/Engineering, 3 years in quality in manufacturing, knowledge of ISO 13485 is preferred, and fluent

Qualifications

• Bachelor degree/diploma in Science or Engineering; or equivalent
• Mechanical or Electronic basis preferred
• 3 years’ quality experience in manufacturing
• Experience in medical devices and ISO 13485 knowledge preferred
• Fluent verbal and written English
• Six Sigma certification a plus
• Good coordination and communication skills

Responsibilities

• Handle internal and external quality issues and customer complaints
• Participate in process or equipment validation review to ensure compliance with quality and regulatory requirements
• Perform batch record reviews and lead initiatives to reduce defects and customer complaints
• Conduct statistical analysis of quality process data; interpret, compile and organize results to identify opportunities for improvement
• Update and maintain quality documentation such as Master validation plan, PFMEA, Control plan and SOPs
• Work with cross-functional teams on failure investigations, including NCR, deviation, complaint and field return issues; monitor effectiveness of corrective actions
• Provide feedback to relevant functions for further analysis and improvement; ensure closure of cases
• Authorize to place on-hold products and stop production in case of critical quality issues
• Ensure implementation of Health, Safety & Environmental procedures
• Contribute and implement ideas that improve performance
• Perform other tasks assigned by the superior

Skills

Quality management

Statistical analysis

Process validation

Document control

Team coordination

English proficiency

Education

Bachelor or Diploma in Science or Engineering

Tools

Microsoft Office

Job description

About the role We are seeking a Quality Engineer to join GN ReSound (Malaysia) Sdn Bhd in Kulai, Johor. This is a full-time position that plays a crucial role in ensuring the highest standards of product quality and compliance throughout our manufacturing operations. As a Quality Engineer, you will be responsible for implementing, maintaining, and improving quality management systems, conducting thorough inspections, and driving continuous improvement initiatives. This role is essential to our commitment to delivering reliable, safe, and compliant products to our customers.

Key responsibilities

Handling of internal and external quality issues and customer complaints.

Participate in process or equipment validation review to ensure compliance with quality and regulatory requirements.

Perform batch record reviews and lead initiatives to reduce defects and customer complaints.

Conduct statistical analysis of quality process data; interpret, compile and organize results to identify opportunities for improvement.

Update and maintain quality documentation, such as Master validation plan, PFMEA, Control plan and SOPs

Work with cross-functional teams on failure investigations, including NCR, deviation, complaint and field return issues; monitor the effectiveness of the corrective actions.

Provide feedback to relevant functions for further analysis and improvement; follow up to ensure a timely and effective solution until case closure.

Authorize to place on-hold the products and stopping the production line in the event of critical quality issues or significant deviations from quality standards are detected, ensuring immediate containment to prevent release of defective products.

Ensure implementation, adherence and participation in Health, Safety & Environmental (HSE) procedures by applying to areas of responsibility.

Continuously contribute, develop and implement ideas that improve performance.

Perform other tasks assigned by the superior.

What we're looking for

Bachelor degree/diploma in Science or Engineering discipline or above or meet below working experience requirements.

Mechanical or Electronic Basis preferred

Preferable 3 years’ experience in quality field in manufacturing environment or relevant working experience, good products knowledge.

Experience in medical device and/or knowledge of a wide range of manufacturing technologies is an advantage and ISO 13485 knowledge is preferred

Strong ability on practice and analysis.

Understand requirements of process/equipment validation

6 sigma certificate as a plus

Fluent verbal and written English

Good computer skill of Microsoft application software

Good coordination & communication skill and team spirit

What we offer

We are committed to provide a supportive and rewarding work environment. We offer competitive remuneration packages, including health and medical benefits to support your wellbeing. You will have access to professional development opportunities and training programmes to enhance your skills and advance your career within our organisation. We believe in maintaining a healthy work-life balance and provide a workplace that encourages innovation, continuous learning, and career progression.

GN brings people closer through our leading intelligent hearing, audio, video, and gaming solutions. Inspired by people and driven by innovation, we deliver technologies that enhance the senses of hearing and sight. We help people with hearing loss overcome real-life challenges, improve communication and collaboration for businesses, and provide great experiences for audio and gaming enthusiasts.

GN was founded more than 155 years ago with a vision to connect the world. Today, inspired by our strong heritage, GN touches more lives than ever with our unique expertise and the broadest portfolio of products and services in our history – bringing people closer to what is important to them.

GN brings people closer through our leading intelligent hearing, audio, video, and gaming solutions. Inspired by people and driven by innovation, we deliver technologies that enhance the senses of hearing and sight. We help people with hearing loss overcome real-life challenges, improve communication and collaboration for businesses, and provide great experiences for audio and gaming enthusiasts.

GN was founded more than 155 years ago with a vision to connect the world. Today, inspired by our strong heritage, GN touches more lives than ever with our unique expertise and the broadest portfolio of products and services in our history – bringing people closer to what is important to them.