Vigilance Specialist (full time) - global Medical Devices company
Posted on Feb 14, 2020 by NES IT
NES Global Talent in Switzerland focuses purely in the Life Science sector where we support the Pharma, Medical Device, Biotech industries and work on QA, Technical and Regulatory positions. With a database that consists of over 2000 Life Science involved talents based in Switzerland and a contact that covers 90% of the job seekers we advertise our clients through all recruitment rotes on a daily basis.
Currently we support one of our clients in the Medical Device industry. In order to strengthen their team, we are looking for an experienced professional to join them as the Product Vigilance Specialist to investigate medical complaints and determine their root causes, performing statistical evaluation. Their current and upcoming global projects in Q1 and Q2 predict growth in the Post Market Safety department and they've reached to us for our support.
- Determing the cause of complaint (root cause)
- Perform a device inspection when possible or coordinate with the in-spection cells
- Inroduction of necessary corrective measures (NC/CAPA)
- Analyzing production documents, test certificates, risk assesstments (risk management file), directions (Optech), processing instructions (IFU . Re-processing) etc.
- Creation of statistical analysis (Trending)
- Documentation of complaint data and test results in the global complaint system (CHF/TrackWise/suPER)
- Connect with other department (R&D, manufacturing, RA, marketting logistics, customer services) and attending meetings.
- Coordinate investigations on early products surveillance process
- Provide necessary information on regilatory compliance organization tasks
- Proxy for CAPA/RM boards/Presentation
- Technical or Management education
- Processing complaint investrigations in the complaint database
- Project Leading
- MS Office
- QMS Knowledge (better if in relation to medical devices)
- Optimal: Complaints Processing of medical devices (Post Market Vigilance), Implementation of corrective action (NC/CAPA), working in an interdisciplinary team
- Good organizational and communication skills, team platyer, fast learner, leadership
- Fluentcy in English (French and/or German is a plus)
- Detailed conversation, introduction and preparation for a successful application with an experienced consultant
- Transparency and support throughout the application process
- Negotiation with clients for better work/contract conditions
- Follow up and update on market relevant opportunities
Experience in within the EU is needed. Please note we can only accept applications from candidates who hold valid European Union passport and are able to work in Europe without visa sponsorship.
Keywords: medical device, vigilance, post market safety, global projects, investigation, management, complaints, surveillance, medical devices, root cause, statistical evaluation
Established in 1978, NES Global Talent provides a complete range of contract and permanent talent solutions to the Oil and Gas, Power, Construction and Infrastructure, Life Sciences, Manufacturing and IT sectors worldwide. With more than 40 offices in 28 countries, we are able to provide our clients with the engineering and technical expertise they need, wherever and whenever it is needed. Offering far more than a traditional recruitment service, we fully support our contractors while they are on assignment with everything from securing visas and work permits, to providing market leading benefits packages and accommodation, ensuring they are safely and compliantly able to support our clients.