Quality Manager, Medical Devices & Regulatory Leadership

Radiometer; Pasir Gudang; On-site; MYR 180,000 - 260,000; Full time

Benefits offered by this job

Bonus up to 10%

Job summary

Masimo, a Danaher operating company, is seeking a QUALITY Manager to uphold the highest quality, regulatory, and compliance standards across manufacturing. This on-site role is based in Pasir Gudang, Johor and reports to the General Manager.

You will develop and maintain a robust QMS aligned with ISO 13485 and FDA guidelines, lead supplier audits, manage risk, and collaborate with R&D, manufacturing and regulatory authorities to embed quality throughout the product lifecycle.

Qualifications

• Bachelor’s or Master’s degree in engineering, quality management, life sciences, or related field.
• Extensive experience in quality management for medical device/pharma manufacturing.
• Strong knowledge of ISO 13485, FDA QSR, and EU MDR plus Six Sigma/Lean methods.

Responsibilities

• Develop and maintain an effective QMS compliant with ISO 13485 and FDA guidelines.
• Lead quality audits, supplier qualification, and risk management processes.
• Collaborate with R&D, manufacturing and regulatory authorities to embed quality across the product lifecycle.

Skills

Quality management

Regulatory compliance

Six Sigma

Lean

Team leadership

Analytical thinking

Education

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

Job description

Masimo, a Danaher operating company, is seeking a QUALITY Manager to uphold the highest quality, regulatory, and compliance standards across manufacturing. This on-site role is based in Pasir Gudang, Johor and reports to the General Manager.

You will develop and maintain a robust QMS aligned with ISO 13485 and FDA guidelines, lead supplier audits, manage risk, and collaborate with R&D, manufacturing and regulatory authorities to embed quality throughout the product lifecycle.