Quality Assurance Specialist, Medical Devices (m/f)
At Onyx Circle we bring together companies and talents, who want to create a common future. We are Recruiting Experts within the areas of Construction & Real Estate, Engineering & Manufacturing as well as Digitalization. Thanks to our experience, we`ve been developing ourselves as a competent partner for both our clients and candidates.
Within the Engineering & Manufacturing division we`re specializing in identifying talents in the industry as well as medical technology, specifically we`re permanently looking for Service Engineers, Automation Engineers, Quality Professionals as well as R&D Managers.
About our client
Our client is a manufacturer of Ventilation & Monitoring devices and based in the surrounding of Zurich. Due to the current situation the company is experiencing a high demand in their devices and we`re therefore looking for a Quality Assurance Specialist to be mainly involved in complaint handlings, risk assessments as well as CAPA management. The position is to be filled as soon as possible or as per agreement.
- Responsible for conducting complaint handlings, CAPA management as well as risk assessments
- Perform and support complaint investigations
- Ensure timely review and follow-up on complaints together with providing feedback to internal stakeholders and customers
- Review and submit Manufacturing Incident Reportings to internal and external authorities
- Act as the main contact person related to complaints
- Organize relevant Subject Matter Experts to provide reliable information and feedback
- Collect and analyze data from the market
- Update relevant documentations, which includes updating of relevant procedures with regards to complaints
- Supporting function related to the EU MDR implementation
- Technical background is desired, e.g. in Engineering
- Some years of experience within a similar role, preferably in a Medical Device Environment
- Familiar with ISO and FDA requirements (i.e. ISO13485:2016, ISO14971, 21CFR820, 93/42 MDD)
- Proven knowledge of MDR requirements
- Ability to train, mentor and work well with others
- Excellent skills in verbal, written and graphical communication
- Good inter-personal skill, attitude and work ethic
- Fluency in English and German is required
In this role as Quality Assurance Specialist you will actively improve patient outcomes and therefore have a big impact on the short- and long-term success of the company. You will act as an interface between executives within the organization, support your team members and therefore create an inspiring place to work. Are you the candidate we are looking for? We are looking forward to receiving your application!
Onyx Circle AG
Tel.: 081 377 71 71
Mobil: 079 227 98 98