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:
You will play a key leadership role in shaping and executing site-level quality strategies. Your mission: ensure our quality operations meet the highest standards of compliance with international medical industry regulations and our internal quality systems. As the Director of our Quality Operations and Quality Engineering teams in Europe, you’ll collaborate closely with both local and global stakeholders to uphold excellence across all manufacturing processes. From product development to final release, your guidance will be instrumental in maintaining the integrity, safety, and regulatory compliance of our products, ultimately contributing to improved patient outcomes worldwide.
Roles & Responsibilities:
* Direct quality operations for European sites in Germany and Bulgaria, overseeing functions including IQC, MRB, PMC, FQI, DHR, and Quality Engineering.
* Develop and execute site and regional strategies aligned with company goals and customer expectations, driving continuous improvement in quality metrics.
* Lead quality assurance and compliance activities to ensure the highest product quality, prevent defects, and resolve issues through root cause analysis.
* Create, monitor, and control quality operations budgets while planning resources based on company growth projections.
* Foster an inclusive and diverse culture that promotes collaboration across organizational and geographical boundaries, motivating employees to produce their best work.
* Collaborate with operations teams and other partners to implement quality strategies and achieve measurable results.
* Develop, trend, and improve quality operational metrics, collecting and analyzing product quality data to drive process improvements.
* Ensure adherence to internal procedures and regulatory requirements, providing guidance and support to the team as needed.
* Conduct organizational talent planning to identify needs and develop growth plans for quality team members.
Qualifications
Required Knowledge, Skills, and Experience:
* Bachelor’s degree in Electronics, Biomedical, or related engineering field.
* Minimum of 5 years of experience as a Quality Director in the medical industry, preferably with multiple site responsibilities.
* Proven experience in managing quality functions such as IQC, MRB, PMC, FQI, DHR, and Quality Engineering.
* Demonstrated proficiency in developing site and regional strategies aligned with corporate and customer goals.
* Familiarity with international medical regulations and deep knowledge of ISO 13485 standards.
* Expertise in using statistical tools, including Measurement System Analysis (MSA), to drive continuous improvement initiatives.
* Strong capability in reading and interpreting technical drawings and quality documentation.
* Advanced knowledge of Office software packages and intermediate experience working with SAP systems.
* Certification in Six Sigma or similar methodologies is highly desirable.
* Excellent verbal and written German and English communication skills, with experience fostering inclusive and diverse work environments.
Additional Information
Wir schätzen jede Person in ihrer Individualität – unabhängig von Geschlecht, ethnischer oder sozialer Herkunft, Religion, besonderen Bedürfnissen, Alter oder sexueller Identität. Diskriminierung hat bei uns keinen Platz.
Shift: Day