Quality Systems Engineer - QMS & Compliance Lead

Straits Orthopaedics (Mfg) Sdn Bhd; Batu Kawan; Presencial; MYR 70.000 - 110.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Communication skills

Teamwork

English

Bahasa Malaysia

Educación

Bachelor’s degree in Engineering

Herramientas

Microsoft Excel

Microsoft Word

Descripción del empleo

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.