Quality Engineer

Straits Orthopaedics (Mfg) Sdn Bhd; Seberang Perai; On-site; MYR 48,000 - 72,000; Full time

Job summary

Straits Orthopaedics (Mfg) Sdn Bhd is seeking a Quality Assurance Auditor to lead QMS audits and ensure all procedures align with the company’s quality system. You will review practices, initiate improvements, and support non-conformity investigations to maintain compliance with ISO 9001 and FDA requirements.

The role requires a Bachelor’s degree in Engineering, strong communication skills in English and Bahasa Malaysia, and the ability to work both independently and in a team.

Qualifications

• Candidates must possess at least Bachelor’s Degree in Engineering.
• Required skills: Computer literate, Microsoft Excel, Microsoft Word
• Proficient: English and Bahasa Malaysia
• Must be able to work in a team and independently;
• Good understanding of the requirements of ISO and FDA requirements.
• At least 3 years of working experience in company with ISO 9001 certification or equivalent.
• Strong written and verbal communication and presentation skills. Ability to present and effectively communicate complex technical data to audiences of various backgrounds and knowledge levels.

Responsibilities

• Prepare and perform QMS audits to insure that all procedures and instructions related to the QMS are adhered to
• Ensure that all current practices are in compliance with the company's quality management system. Otherwise, revise and update the procedures to reflect current practices.
• Initiate action to prevent the occurrence of non-conformities related to product, processes, and quality system. This includes halting the production of any product to correct quality problems.
• Identify and record any problems related to the product, process, or quality system
• Provide technical support for issues related to new products, new customers, and/or qualification of new equipment and personnel
• Track and prepare monthly reports for internal and external quality performance metrics.
• Perform checks from time to time on the document control records in the production departments.
• Train Quality Inspectors and Lead Hands to follow Quality Inspection Instructions.
• Lead the investigation of customer non-conformance reports
• Any other duties and responsibilities assigned by the management from time to time.

Skills

Computer literacy

Microsoft Excel

Microsoft Word

English

Bahasa Malaysia

Teamwork

Independent work

Quality awareness

Education

Bachelor’s Degree in Engineering

Tools

Microsoft Excel

Microsoft Word

Job description

Jora Malaysia will close on 9th September 2026. Thank you for being with us, we are cheering you on as you continue your career journey.

Job Description

• Prepare and perform QMS (Quality Management System) audits to insure that all procedures and instructions related to the QMS are adhered to
• Ensure that all current practices are in compliance with the company's quality management system. Otherwise, revise and update the procedures to reflect current practices.
• Initiate action to prevent the occurrence of non-conformities related to product, processes, and quality system. This includes halting the production of any product to correct quality problems.
• Identify and record any problems related to the product, process, or quality system
• Provide technical support for issues related to new products, new customers, and/or qualification of new equipment and personnel
• Track and prepare monthly reports for internal and external quality performance metrics.
• Perform checks from time to time on the document control records in the production departments.
• Train Quality Inspectors and Lead Hands to follow Quality Inspection Instructions.
• Lead the investigation of customer non-conformance reports
• Any other duties and responsibilities assigned by the management from time to time.

Requirements

• Candidates must possess at least Bachelor’s Degree in Engineering.
• Required skills: Computer literate, Microsoft Excel, Microsoft Word
• Proficient: English and Bahasa Malaysia
• Must be able to work in a team and independently;
• Good understanding of the requirements of ISO and FDA requirements.
• At least 3 years of working experience in company with ISO 9001 certification or equivalent.
• Strong written and verbal communication and presentation skills. Ability to present and effectively communicate complex technical data to audiences of various backgrounds and knowledge levels.