Sr Supplier Quality Engineer
Intuitive

Job Info

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At Intuitive, 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. Our mission is our guiding force; our culture is the DNA that makes us unique.

As a pioneer in robotic-assisted surgery (RAS), we have been expanding our innovations through technology to help make a difference in the world. For 25 years, human ingenuity has guided our journey to help solve some of healthcare’s complex challenges.

We believe a great idea can come from anywhere—inclusion and mutual respect are vital to our culture. We value character grounded in integrity, a strong capacity to learn, the energy to get things done, and diverse 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 strive to 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 help to advance the world of minimally invasive care.

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 and Responsibilities:

This position has responsibility and authority to:

• 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

Skill/Job Requirements:

To adequately perform the responsibilities of this position the individual must possess:

• Minimum of a BS degree in Engineering or equivalent, Masters degree preferred
• Minimum 10 years related experience in Supplier Quality and/or Supplier Development or related field
• Excellent knowledge of 21 CFR part 820, ISO 13485:2016, EUMDR, MDSAP regulations (experience in auditing suppliers to these standards)
• Certified Lead auditor credentials preferred
• 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, Trackwise 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

 

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19.  Details can vary by role.

 

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.

Shift : Shift 1 - Day

Travel : Yes, 25 % of the Time

Travel Requirements:Yes, 25 % of the Time Shift:Shift 1 - Day

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