Remote Supplier Quality Engineer - Audits & Compliance

Intuitive

George Town

Remote

MYR 286,000 - 490,000

Full time

8 days ago

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Job summary

Intuitive is seeking a Supplier Quality Engineer to ensure compliance of supplier controls with ISO 13485:2016, MDSAP, and EU MDR. You will lead supplier audits, drive CAPAs, manage SCARs, and oversee supplier performance with cross-functional teams across Purchasing, Product Quality, and Supplier Engineering.

You will also guide ASL maintenance, monitor supplier data, and support internal and external audits (FDA, MDSAP, EU MDR).

Qualifications

Minimum 3 years of related experience in Supplier Quality and/or Supplier Development or a related field.
Excellent knowledge of 21 CFR Part 820, ISO 13485:2016, EU MDR, and MDSAP regulations, with demonstrated auditing experience.
Strong communication and leadership skills in engineering-driven environments.

Responsibilities

Conduct assigned Supplier Audits as Lead Auditor per Global Supplier Audit.
Schedule Pre-Audit activities and Post-Audit actions.
Execute Audit Reports with Audit Response Forms and Supplier Responses.
Own Supplier Quality processes including Supplier Controls and Global Supplier Manual.
Lead Supplier Monitoring and evaluation activities with cross-functional stakeholders.
Run quarterly Supplier Monitoring Boards and present health metrics.