Lead Auditor, Supplier Quality Engineer (Remote)

Intuitive; Penang; Remote; MYR 90,000 - 140,000; Full time

Job summary

Intuitive is seeking a Supplier Quality Engineer to ensure compliance of Supplier Controls with ISO 13485, MDSAP, EU MDR and other regulations. You will audit suppliers as Lead Auditor and drive CAPAs and supplier monitoring across global sites.

You will lead cross-functional teams, manage SCARs, and guide regional teams on supplier selection, onboarding, and quality elements of supplier agreements. Travel up to 50% domestically and internationally.

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 experience auditing suppliers to these standards.
• Ability to work with highly technical teams and communicate effectively in an engineering-driven environment.
• Strong organizational, written, and verbal communication skills with proven ability to prioritize tasks in a deadline-driven environment.
• Excellent presentation skills, including executive-level management presentations.
• Excellent leadership and project management skills.
• Significant computer experience using Windows, Word, Excel, Agile, Trackwise, SAP and basic AI prompts.
• Ability to read and interpret detailed mechanical drawings and communicate technical information.

Responsibilities

• Conduct assigned Supplier Audits as Lead Auditor per Global Supplier Audit.
• Schedule, including Pre-Audit activities and Post-Audit actions.
• Execute Audit Reports with necessary Audit Response Forms and Supplier Responses.
• Own Supplier Quality processes including Supplier Controls, Global Supplier Manual,
• Supplier Selection, Evaluation and Re-Evaluations, SCAR Process, and Supplier Monitoring as a Corporate Business Process Owner.
• Run quarterly Supplier Monitoring Boards with cross-functional stakeholders, presenting Supplier Quality health metrics on Audits, SCARs, Supplier nonconformances, and ASL.
• Periodically analyze and review Supplier Controls processes in partnership with Regulatory Affairs/Quality Systems team to maintain compliance with latest applicable Regulations and Standards.
• Lead internal CAPAs related to Supplier Controls.
• Lead high-visibility SCARs and Key Supplier Audits (Evaluations and Re-Evaluations) as Lead Auditor.
• Guide Process Managers on ASL maintenance and Supplier promotions and removals.
• Support Internal and External Audits (FDA, MDSAP, EU MDR, etc.) representing Supplier Quality in Audit Front Rooms.
• Lead Projects as Project Manager to improve Supplier Controls Processes for efficiency and compliance.
• Serve as technical custodian of Supplier Data Monitoring and Analysis; analyze and prepare data for Supplier Monitoring Boards and monitor tools and dashboards for accuracy.
• Review and Approve Product SCARs; serve as board member for SCAR Review Boards.
• Provide guidance to International Intuitive Sites on Local/Regional Supplier Controls execution and maintenance.
• Provide guidance to NPI Project teams on Supplier Selection and onboarding.
• Guide Purchasing department on Quality elements of Supplier Agreement negotiations.

Skills

Supplier Quality

Supplier Development

Regulatory Auditing

Communication Skills

Leadership

Project Management

SAP

TrackWise

MS Office

Mechanical Drawings

Education

BS in Engineering

Masters in Engineering

Certified Lead Auditor (EUMDR, QMSR)

Tools

Windows

Microsoft Word

Microsoft Excel

Agile

TrackWise

SAP

Job description

Intuitive is seeking a Supplier Quality Engineer to ensure compliance of Supplier Controls with ISO 13485, MDSAP, EU MDR and other regulations. You will audit suppliers as Lead Auditor and drive CAPAs and supplier monitoring across global sites.

You will lead cross-functional teams, manage SCARs, and guide regional teams on supplier selection, onboarding, and quality elements of supplier agreements. Travel up to 50% domestically and internationally.