Quality Documentation Specialist (ISO 13485 & CAPA)

Menicon Malaysia Sdn Bhd; Kedah; On-site; MYR 40,000 - 60,000; Full time

Job summary

A leading document management company in Kedah, Malaysia, is seeking a Document Control Specialist to oversee the document management process. The ideal candidate will ensure compliance with ISO 13485 standards and perform quality checks on documentation. A Bachelor's degree in Science or Engineering is required, along with effective communication skills and proficiency in Japanese. This role offers the opportunity to manage internal and external document processes and participate in audits.

Qualifications

• Minimum one year experience in manufacturing or fresh graduate.
• English is a must; Bahasa and others will be an added advantage.

Responsibilities

• Review records to assure adherence to ISO 13485 compliance.
• Perform quality checks on documents for Good Documentation Practices.
• Coordinate internal, external audits and management review meetings.
• Manage and monitor document control processes.
• Coordinate Non-Conformance and CAPA processes.
• Ensure all documentation is up to date and accurate.
• Manage document filing, distributing, and archiving processes.
• Perform any other related duties as assigned.

Skills

Effective communication skills

Proficiency in Japanese language

Proficiency in documentation tools (Microsoft Word, Excel, PowerPoint)

Education

Bachelor's degree in Science or Engineering

Job description

A leading document management company in Kedah, Malaysia, is seeking a Document Control Specialist to oversee the document management process. The ideal candidate will ensure compliance with ISO 13485 standards and perform quality checks on documentation. A Bachelor's degree in Science or Engineering is required, along with effective communication skills and proficiency in Japanese. This role offers the opportunity to manage internal and external document processes and participate in audits.