Supplier Quality Engineer

Intuitive; George Town; Remote; MYR 286,000 - 490,000; Full time

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.

Skills

Supplier Quality Regulations

Audit Lead

Cross-functional communication

Executive-level presentation

Project management

Data analysis

SAP

Trackwise

Agile

Windows/Office tools

Education

BS in Engineering

Tools

SAP

Trackwise

Job description

• Ways of Working: Remote - This job will be remote and/or the job is designed to be performed outside of the office. Employees will come onsite when requested by the leader.
• Employee Type: Employee
• Global Job Level (HCM): Professional 3 (9)

Job Description

Primary Function of Position
The Supplier Quality Engineer reports to the Manager, Global Supplier Quality and is responsible for ensuring compliance of Intuitive's Supplier Controls with applicable regulations and standards including ISO 13485:2016, MDSAP, and EU MDR. The SQE partners with cross-functional teams — Purchasing, Product Quality, Supplier
Development, and Supplier Engineering — to improve Supplier Controls Business Processes. Key functions include conducting key Supplier Audits as Lead Auditor, Supplier Monitoring Boards, managing Internal CAPAs related to supplier controls, driving high-visibility SCARs.
Essential Job Duties

• 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.

Qualifications

Required Skills and Experience

• 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.

Required Education and Training
BS degree in Engineering or equivalent.
Working Conditions
Ability to travel to suppliers and other Intuitive sites on an as-needed basis (approximately 50%), both domestically and internationally.
Preferred Skills and Experience

Additional Information

Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

U.S. Export Controls Disclaimer:In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employeeswho are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).

For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’sstart date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.

This position may be filled at a different job level than listed here depending
business need and/or on the selected candidate’s experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidate’s qualifications, consistent with applicable law.