Quality Management System Sr Manager - Aubonne - Switzerland
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