Summary
We are currently recruiting an experienced “Quality Systems Manager”. Working within a multi-disciplinary team, the role will primarily involve implementing and managing quality systems and compliance as the company develops next-generation products, including devices, software and services, for our next generation of wearable medical monitors and systems.
Medical Devices, Wearables, Sensors, Hardware (St Ives)
*£45,000 - £55,000 depending on experience
Aseptika began developing Activ8rlives (www.activ8rlives.com) in 2010 and is now in its third generation of integrated systems, which can be used by consumers and their healthcare service providers. Platforms range from consumer accessories to in vitro diagnostics (IVDs), with a focus on respiratory and cardiovascular disease, cancer, promoting physical activity, and weight management.
We are currently recruiting an experienced “Quality Systems Manager”. Working within a multi-disciplinary team, the role will primarily involve implementing and managing quality systems and compliance as the company develops next-generation products, including devices, software and services, for our next generation of wearable medical monitors and systems.
Key Requirements
- Understanding the overall quality accreditation process, and maintaining compliance.
- Experience working within the medical device quality sector.
- Thorough understanding of legislation ISO13485, EU MDD 93/42/EEC, FDA CFR 820.
- Experience in gaining CE marking and Design history files.
This is an exciting role for someone looking to progress into a senior position. If you are interested in being involved in this opportunity, please send a brief covering letter and CV, with your location, current salary and notice period to jessica.auton@aseptika.com
No Agencies please. This position is not being advertised with agencies.
We will be unable to accept applicants from outside the EU if Right to Work visas are not already in place.
Job Type: Full-time
Office address
St Ives
