Sr Supplier Quality Engineer - EMEA

Company Description

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.

As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.

Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.

Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.

Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

 

Job Description

Primary Function of Position:

Senior Supplier Quality Engineer (Sr SQE) will provide expertise and support compliance of Intuitive's Supplier Controls with all applicable Regulations and Standards (ISO 13485:2016, MDSAP, EUMDR etc.). S/he will work with cross functional organizations (Purchasing, Product Quality, Supplier Development and Supplier Engineering) to improve Supplier Controls Business Processes. Sr SQE will lead Supplier Monitoring Boards, Internal CAPAs (related to supplier controls), high visibility SCARs and key Supplier Audits.

Roles & Responsibilities:

• 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 the status of Supplier Quality health with metrics on Audits, SCARs, Supplier nonconformances and ASL.
• Work with Regulatory affairs/Quality Systems team and Periodically analyze and review Supplier Controls processes to stay in 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 a Lead Auditor.
• Guide Process Managers on ASL maintenance and Supplier promotions and removals.
• Support Internal and External Audits (FDA, MDSAP, EUMDR etc.) representing Supplier Quality in Audit Front rooms.
• Lead Projects as a Project Manager to improve Supplier Controls Processes to improve efficiency and compliance.
• Be a 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 and be a 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 negotiation with Suppliers

Qualifications

Skills, Experience, Education, & Training:

• Minimum BS degree in Engineering or equivalent, Masters degree preferred
• Minimum 8-10 years related experience in Supplier Quality and/or Supplier Development, Supplier Engineering or related field
• Expertise in one or more of the following commodities: metals, plastics, electronics, contract manufacturing, OEM, distribution, or services.
• Expertise in statistical process control, root cause analysis and corrective/preventive actions
• Excellent knowledge of 21 CFR part 820, ISO 13485:2016, EUMDR, MDSAP regulations (experience in auditing suppliers to these standards)
• Certified Lead auditor credentials
• Ability to be a true team player and a partner to the cross functions teams; be part of the solution and demonstrate ability to use sound judgment in implementing practical Quality System and Compliance solutions.
• Ability to work with highly technical teams and effectively communicate in an engineering driven team environment
• Strong organizational, written, and verbal communication skills and the proven ability to prioritize tasks effectively in a deadline-driven environment
• Excellent written and verbal communication skills including presentations to executive level management
• Excellent Leadership and Project Management skills
• Significant computer experience using Windows, Word, Excel, Agile, and SAP
• Ability to read and interpret detailed mechanical drawings and communicate technical information
• Ability to travel to Suppliers/other Intuitive Sites on an as needed basis (30%) - domestic and international

Additional Information

Intuitive ist ein Arbeitgeber, der gleiche und gerechte Beschäftigungsmöglichkeiten bietet. Wir bieten allen qualifizierten Bewerbern und Mitarbeitern gleiche Beschäftigungsmöglichkeiten, unabhängig von ethnischer Herkunft, Geschlecht, Schwangerschaft, sexueller Orientierung, Geschlechtsidentität, nationaler Herkunft, Hautfarbe, Alter, Religion, geschütztem Veteranenstatus, Behindertenstatus, genetischen Informationen oder einem anderen Status, der nach den geltenden Gesetzen auf Bundes-, Landes- oder lokaler Ebene geschützt ist, und verbieten jegliche Form von Diskriminierung und Belästigung.

Gemäß den „Fair Chance“-Gesetzen berücksichtigen wir qualifizierte Bewerber, die verhaftet wurden oder Vorstrafen haben, für offene Stellen.