Quality Engineer

Straits Orthopaedics (Mfg) Sdn Bhd; Batu Kawan; On-site; MYR 70,000 - 110,000; Full time

Job summary

Straits Orthopaedics (Mfg) Sdn Bhd in Batu Kawan seeks a QA/QMS Engineer to perform audits and ensure adherence to the quality management system. You will update procedures to reflect current practices and drive non-conformance investigations.

The role requires 3+ years in an ISO 9001 certified environment, strong English and Bahasa Malaysia, and the ability to communicate complex data to diverse audiences. Join a growing medical devices manufacturer exporting globally.

Qualifications

• Bachelor’s degree in Engineering required.
• Proficient with Microsoft Excel and Word.
• Fluent in English and Bahasa Malaysia.
• Able to work in a team and independently.
• Strong understanding of ISO 9001 and FDA requirements.
• At least 3 years of working experience in a company with ISO 9001 certification or equivalent.
• Strong written and verbal communication and presentation skills.

Responsibilities

• Prepare and perform QMS audits to ensure procedures and instructions are adhered to.
• Ensure current practices comply with the QMS and update procedures as needed.
• Initiate action to prevent non-conformities related to product, processes, and quality system, including halting production if required.
• Identify and record problems related to product, process, or quality system.
• Provide technical support for issues related to new products, customers, and equipment/personnel qualification.
• Track and prepare monthly reports for internal and external quality metrics.
• Perform checks on document control records in production departments.
• Train Quality Inspectors and Lead Hands to follow Quality Inspection Instructions.
• Lead investigations of customer non-conformance reports.
• Any other duties assigned by management.

Skills

Communication skills

Teamwork

English

Bahasa Malaysia

Education

Bachelor’s degree in Engineering

Tools

Microsoft Excel

Microsoft Word

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.

Straits Orthopaedics (Mfg) Sdn Bhd ("Straits") is a situated at Batu Kawan. Straits is a medical devices manufacturer and our principal business is the production, cleaning and packaging of orthopaedics devices and accessories (trauma and reconstructive ) and wound care products. Mainly, all our product are exported to our customers in the United States of America, China, Japan, Europe etc. Straits is a company certified with ISO 13485 and ISO 9001. Our company is registered with US FDA and is required to comply with 21 CFR Part 820. Currently, we have approximately 1200 employees and due to our expansion, we are looking for qualified candidate to join our team as :

Straits Orthopaedics (Mfg) Sdn Bhd ("Straits") is a situated at Batu Kawan. Straits is a medical devices manufacturer and our principal business is the production, cleaning and packaging of orthopaedics devices and accessories (trauma and reconstructive ) and wound care products. Mainly, all our product are exported to our customers in the United States of America, China, Japan, Europe etc. Straits is a company certified with ISO 13485 and ISO 9001. Our company is registered with US FDA and is required to comply with 21 CFR Part 820. Currently, we have approximately 1200 employees and due to our expansion, we are looking for qualified candidate to join our team as :