On-site Quality Assurance Officer — ISO & CAPA Specialist

Intrinseque Health Pte Ltd.; Malacca City; Vor Ort; MYR 35.000 - 55.000; Vollzeit

Zusammenfassung

Intrinseque Health Pte Ltd. in Melaka is seeking a full-time on-site Quality Assurance Officer to oversee the implementation and maintenance of quality systems in line with ISO and GDPMDS standards for the clinical supply chain.

You will review and update quality documentation and SOPs, monitor regulatory and internal compliance, and coordinate CAPAs to address non-conformities. The role also involves internal quality checks, supporting audits, analyzing data trends, and collaborating with

Qualifikationen

• Candidates should possess skills in Quality Assurance and Quality Management to develop, implement, and maintain robust quality systems.
• Strong Analytical Skills to interpret quality data, identify trends, assess risks, and recommend practical improvements.
• Experience working within ISO-certified environments (e.g., ISO 13485, ISO 9001, ISO 27001) or regulated healthcare, pharmaceutical, or medical device settings is beneficial.
• Strong attention to detail, structured documentation skills, and the ability to follow and refine SOPs are required.
• Effective communication and collaboration skills, with the ability to work cross-functionally with operations, logistics, and project teams.

Aufgaben

• Review and update quality documentation and SOPs.
• Monitor compliance with internal procedures and regulatory requirements.
• Coordinate CAPA to address non-conformities.
• Conduct internal quality checks and support audits/inspections.
• Analyze quality data and trends to drive improvements.
• Collaborate with operations, logistics, and project management teams.
• Assist in training team members on quality policies.
• Contribute to risk assessments and process optimization initiatives.

Kenntnisse

Quality Assurance

Quality Management

Analytical Skills

Jobbeschreibung

Intrinseque Health Pte Ltd. in Melaka is seeking a full-time on-site Quality Assurance Officer to oversee the implementation and maintenance of quality systems in line with ISO and GDPMDS standards for the clinical supply chain.

You will review and update quality documentation and SOPs, monitor regulatory and internal compliance, and coordinate CAPAs to address non-conformities. The role also involves internal quality checks, supporting audits, analyzing data trends, and collaborating with