Director of Quality, European Operations

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 pioneer and leading company in the field of 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:

Under general supervision and in alignment with the Sr. Director of Quality Operations for Sunnyvale and Europe, defines and executes strategies to assure compliance to the quality system and   international regulations of the medical industry by managing the quality operations and quality engineering teams and in collaboration with all local and corporate functions to guarantee and maintain the quality of manufacturing processes, finished product and regulatory compliance.

Roles and Responsibilities:

• Direct responsibility for the European Operations including Biebertal, Emmendingen and Freiburg at Germany, as well as Parmovay, Bulgaria.
• Responsible for the quality functions including IQC, MRB, PMC, FQI, DHR and Quality Engineering.
• Develop site and regional strategies to ensure alignment with our company goals and customer expectations, pursuing continuous improvement in our metrics.
• Creates an environment that is inclusive and diverse allowing employees to be their authentic selves, while motivating them to produce their best work.
• Fosters an inclusive culture built around diversity of thought, collaboration and teamwork across organizational and geographical boundaries; willing to break down functional silos to optimize business results and to facilitate the overall growth of the company.
• Proactively manages quality assurance and compliance activities to produce the highest quality products and prevent defects.
• Create, monitor, and control the quality operations budget for the facilities under responsibility.
• Collaborate with the operations teams as well as other internal and external partners to ensure the strategy is executed to achieve significant and measurable results.
• Track recurring issues and escalating as needed to achieve root cause corrective action.
• Collect, monitor, and escalate product quality data and partner with the appropriate function to resolve problem parts, supplier, processes, etc. to closure.
• Develop, trend, and improve appropriate quality operational metrics.
• Provides support and guidance to lead adhering to our internal procedures and regulatory requirements.
• Performs Organization Talent Plans to assure the identification of talent needs and the development of adequate growth plans.
• Plans resource requirements based on the company growth projections and long-term strategies.

Qualifications

Required Knowledge, Skills, and Experience:

• Education:
  • Electronics, Biomedical, Industrial education or other related engineering
• Other studies:
  • Certification in Six Sigma
    • Desirable, MBA desirable, Certified Lead Auditor desirable
• English language skills:  Written and spoken,
  • German fluency highly desirable
• Systems Management: 
  • Advanced level of Office Package
  • Intermediate level of SAP         
  • Preferably Intermediate level of Agile
• Job or area experience:
  • Quality Director/manager          
  • Quality areas    
  • Medical industry           
• Knowledge / skills:                   
  • Knowledge of Statistical Tools such as MSA (Measurement System Analyst)
  • Knowledge of ISO 13485           
  • Knowledge of medical regulations         
  • Drawings Reading

Additional Information

Intuitive ist ein Arbeitgeber, der gleiche und gerechte Beschäftigungsmöglichkeiten bietet. Wir bieten allen qualifizierten Bewerberinnen und Bewerber 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.

Shift: Day