Intuitive Surgical Careers

Quality Management System Sr Manager - Aubonne - Switzerland

Vaud, Switzerland
Clinical Affairs


Job Description

Job: Clinical Affairs
Primary Location: Switzerland-Vaud
Schedule: Full-time
Requisition ID: 190777

Description

Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.

 

Primary Function of Position:

Develop and lead the quality management system (QMS) in Europe, including certifications, audits, supplier management, distribution centers, document control, training, CAPA, management review; ensures alignment with corporate QMS; drives continuous improvement processes; advises specific in-country needs and remote departments (eg Field Service); support supplier audit and special processes related to sterilization or reprocessing

 

Roles and Responsibilities:

 

Main activities

  • Ensure compliance of the European QMS to applicable QMS regulation, including ISO 13485:2016, EU MDD/MDR, MDSAP and 21 CFR 820

  • Identify QMS gaps and develop solution strategy by implementing and monitoring CAPAs, quality & operational plans, KPIs

  • Promote awareness of applicable QMS and regulatory requirements across the organization

  • Lead complex cross-functional project teams that may be global in nature

  • Advise other departments (sterilization & reprocessing activities, field service,  manufacturing, distribution centers, clinical affairs, …)

  • Act as a central RAQA point between corporate US RAQA and local departments, including remote (Marketing, Sales, Field Service, Clinical Affairs, Sterilization) or local (customer care, HR, contract, IT…) departments

 

Additional activities

  • Other projects may be assigned as necessary

  • People Management: determine goals and objectives while removing obstacles for the team

  • Travel: up to 20%


Qualifications

Required Knowledge, Skills, and Experience:

 

  • At least 10+ years’ experience in medical device industry operating according to US or EU regulation including at least 3 years in medical devices quality system management, quality manufacturing or regulatory affairs
  • A Bachelor degree, Engineering or Master’s degree in medical technology, life sciences or similar (or equivalent work experience in similar function)
  • Team management experience of small team size associated with goals objectives definition / people development
  • Deep knowledge of EU MDD 93/42/EEC, EU MDR 2017/745/EU, US FDA CFR 21, ISO 13485:2016
  • Solid understanding of manufacturing operations, change control, and an awareness of regulatory trends

 

  • Strong interpersonal skills with demonstrated ability to lead projects autonomously and to collaborate effectively with various scientific and business representatives in international team environment
  • Require a highly motivated, resourceful individual who can set goals, work independently and exercise daily judgment based on above regulatory knowledge
  • Demonstrated organizational and planning skills, including action oriented and can-do attitude, focused urgency and driving for results
  • Excellent verbal and written communication and presentation skills, ability to distill complexity and provide clear and actionable direction
  • Orientation for work result details, with emphasis on accuracy and completeness
  • Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook)
  • Language: Fluent English and French or German

 

Preferred Knowledge, Skills, and Experience:

 

  • Lead auditor certification for ISO 9001, 13485 and knowledge of WW regulations
  • Good knowledge of medical device reprocessing/sterilization or refurbishment requirements
  • Project management skills regarding new site implementation / certification