Quality Engineer (Quality Management System)

Straits Orthopaedics (Mfg) Sdn Bhd; Seberang Perai; On-site; MYR 60,000 - 80,000; Full time

Job summary

A leading medical device manufacturer is seeking a Quality Engineer to assist in maintaining and improving the Quality Management System. Responsibilities include process review, audit support, CAPA management, customer complaint handling, and data analysis. The ideal candidate will have a Bachelor's degree in Engineering, at least 3 years of experience in an ISO 9001-certified environment, and strong communication skills. Proficiency in Microsoft Excel and Word is essential, along with fluency in English and Bahasa Malaysia.

Qualifications

• Minimum 3 years experience in an ISO 9001-certified environment.
• Strong knowledge of ISO and FDA quality requirements.
• Ability to convey technical data to diverse audiences.

Responsibilities

• Assist the QMS Manager with QMS maintenance and improvement activities.
• Review QMS adequacy and communicate gaps.
• Manage customer complaints and CAPA logs.

Skills

Process review

Data analysis

Customer complaint handling

Document control

CAPA management

Communication skills

Teamwork

Education

Bachelor’s degree in Engineering or related field

Tools

Microsoft Excel

Microsoft Word

Job description

Quality Engineer (Quality Management System)

Assist the QMS Manager in maintaining and improving the Quality Management System through a variety of tasks including process review, document control, audit support, CAPA management, customer complaint handling, and data analysis.

Responsibilities

• Assist the QMS Manager with QMS maintenance and improvement activities.
• Carry out assigned tasks according to established procedures and report status and issues to the QMS Manager.
• Review QMS adequacy, suitability, and implementation with process owners.
• Identify and communicate QMS process gaps, risk factors, and needed risk mitigation measures.
• Review new QMS documents and document change requests, communicate concerns, and advise document owners on approvals and risk.
• Monitor QMS implementation, nonconformities, and propose improvement actions to process owners and management.
• Collect, analyze, and report on QMS data to measure process performance and identify improvement opportunities.
• Support QMS audit planning and execution, including preparation, involvement, and responding to audit findings.
• Manage customer complaints: investigate, coordinate corrective actions, and close investigations while retaining records.
• Issue and manage CAPA logs, track status, and present closure proposals to management.

Qualifications & Experience

• Bachelor’s degree in Engineering or related field.
• At least 3 years of experience in an ISO 9001‑certified environment or equivalent.
• Good knowledge of ISO and FDA quality requirements.
• Strong written and verbal communication and presentation skills; ability to convey technical data to diverse audiences.
• Proficient in Microsoft Excel, Word, and general computer literacy.
• Fluency in English and Bahasa Malaysia.
• Team player with ability to work independently.