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 a 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 in 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.
• Create an environment that is inclusive and diverse, allowing employees to be their authentic selves, while motivating them to produce their best work.
• Foster 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 facilitate overall growth.
• Proactively manage 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 operations teams and other internal and external partners to ensure strategy execution and achieve measurable results.
• Track recurring issues and escalate as needed to achieve root cause corrective actions.
• Collect, monitor, and escalate product quality data and partner with appropriate functions to resolve issues related to parts, suppliers, processes, etc.
• Develop, trend, and improve quality operational metrics.
• Provide support and guidance to ensure adherence to internal procedures and regulatory requirements.
• Perform organization talent plans to identify talent needs and develop growth plans.
• Plan resource requirements based on company growth projections and long-term strategies.

Qualifications

Required Knowledge, Skills, and Experience:

• Education: Electronics, Biomedical, Industrial engineering or related fields.
• Certifications: Six Sigma (desirable), MBA (desirable), Certified Lead Auditor (desirable).
• Language skills: Written and spoken English; German fluency highly desirable.
• Systems Management: Advanced Office, Intermediate SAP, preferably Intermediate Agile.
• Experience: Quality Director/Manager, experience in quality areas within the medical industry.
• Knowledge/Skills: Statistical tools (e.g., MSA), ISO 13485, medical regulations, reading drawings.

Additional Information

Intuitive is an equal opportunity employer, providing equal employment opportunities regardless of ethnicity, gender, pregnancy, sexual orientation, gender identity, national origin, race, age, religion, protected veteran status, disability, genetic information, or other legally protected status. We prohibit discrimination and harassment.

Shift: Day

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