Impactful Quality Auditor — Life Sciences & Compliance

Radiometer; Pasir Gudang; On-site; MYR 60,000 - 100,000; Full time

Benefits offered by this job

Bonus up to 10% of base salary

Job summary

Masimo, a Danaher operating company, seeks a Quality Auditor to execute internal audits and manage the audit lifecycle at our Pasir Gudang site in Johor. Responsibilities include supporting audits, analyzing trends, and driving improvements in the quality management system.

The ideal candidate will have strong regulatory knowledge, excellent communication, and the ability to work with minimal supervision in a on-site setting.

Qualifications

• Bachelor’s or master’s degree in engineering, Quality Management, Life Sciences, or an equivalent combination of education and related experience.
• Expertise in FDA 21CFR Part 820(QSR), ISO 13485, SOR 98-282 CMDR; Malaysia Medical Device Authority Act 2012 (Act 738).
• Excellent communication skills and the ability to express ideas both orally and in written form.

Responsibilities

• Maintain and support Audit processes.
• Assist with trend analyses related to audits (e.g. types/number of observations).
• Identify and communicate opportunities to improve the quality management system.

Skills

Auditing experience

Quality systems

Regulatory knowledge

Communication skills

Organizational skills

Education

Bachelor's or Master's degree in Engineering/Quality Management/Life Sciences

Job description

Masimo, a Danaher operating company, seeks a Quality Auditor to execute internal audits and manage the audit lifecycle at our Pasir Gudang site in Johor. Responsibilities include supporting audits, analyzing trends, and driving improvements in the quality management system.

The ideal candidate will have strong regulatory knowledge, excellent communication, and the ability to work with minimal supervision in a on-site setting.