Quality Systems Specialist
Distalmotion SA, Switzerland
Job Description
About us
At Distalmotion, we believe that every patient undergoing minimal invasive surgery should benefit from the best of surgical expertise and robotic technology. This is the vision that made us create Dexter, the world’s first and only on-demand robotic surgery system. Thanks to Dexter, surgeons have never been closer to their patients while benefiting from robotic best-in-class technology.
Distalmotion has been created in 2012 by passionate and open-minded people with various experiences. Today, we are still convinced that an inclusive and international company culture is the best way to continue growing. Our leadership is highly committed to promote diversity among the teams and welcome every employee based on their identity.
You are looking for a new fulfilling challenge in a fast-growing medical device company? Join a team engaged in making on-demand robotic surgery the new medical revolution.
About Quality Systems Specialist
Responsibility for the development, structure, maintenance, and improvements to the Quality Management System.
Tasks:
- Lead identification, development, architecture, and optimizations of the Quality Management System, at both Global and Site levels.
- Work collaboratively and support process owners in reviewing, structuring, and documenting their functional new or improved processes.
- Analyze existing processes and ensure integration and consistency across shared, linked, and cross-functionally dependent processes.
- Author procedures, policies, work instructions, and related documents with style, content, and format guidelines in compliance with ISO 13485, 21CFR820, EU MDR and other applicable regulations.
- Actively monitor effectiveness of the quality management system and propose and execute improvement projects.
- Lead complex quality initiatives (e.g. CAPA, process improvements, new processes, gap analyses, system integrations), make recommendations, develop and execute plans.
- Plan and conduct internal audits by participating and leading internal audits, follow up on the findings with auditee through effective closure, and present the data for trending.
- Support electronic QMS transition and take ownership of the software tools including QMS documentation and change control.
- Other duties as assigned.
Requirements:
- Degree in Engineering, Scientific.
- 7+ years of quality-related system experience in a medical device company developing medical devices.
- Excellent technical writing, proofing, and language (grammar and spelling) skills with strict attention to detail.
- Significant knowledge of medical device Quality Management Systems (ISO 13485, 21 CFR 820) and regulatory landscape (i.e. MDR).
- Excellent communication skills and interpersonal relationship skills including negotiating and relationship management skills.
- Advanced problem-solving, organizational, analytical and critical thinking skills.
- Certified lead auditor.
- Electronic QMS experience is preferred.
- Excellent command of English language.
Benefits:
- Opportunity to work in a fast-growing company active in one of the most promising fields of medicine.
- Permanent contract with 25 days of paid vacation.
- A dynamic atmosphere in an internationally minded environment.
- Benefit from one day per week working remotely to boost flexibility.
- Other benefits : Mobility plan, competitive company pension plan, support for gym memberships.
- Regular team building events such as boot camps, skiing and much more.
Distalmotion is a medical device company founded and based in Lausanne, Switzerland. It was founded in 2012, as a spin-off from the Robotics Lab of the Swiss Federal Institute of Technology in Lausanne (EPFL).Our objective is to remove the complexity out of robotic surgery in order to fast track its widespread adoption in minimally invasive care. To do so, we want to continue disrupting minimal invasive surgery - but we will only succeed with the right people on our team. Join our team to address critical healthcare needs and improve patients’ lives !
For further information visit: dexter.surgery and follow us on LinkedIn/Twitter: @Distalmotion.