We are working with experts in medical devices related to physiology, with particular focus on cardiac electro physiology tracking & nerve pain tracking technology. They are searching for a Complaints Specialist/ CAPA Manager to head their complaints function. Their devices are life savings as the conditions they help treat can become life threatening in a very short space of time. Their devices are active devices with embedded software. Both their production site and HQ are based locally in Freiburg, maintaining a close connection between production, planning, management, and RA/QM. This is an exciting time to join as their business priority and agenda is the release of new products over the next few years, allowing you the opportunity to grow as they grow. They have huge plans for expansion in 2022. Their products are sold globally.
The plans have already been set in motion in the past few years, starting with restructuring and newly created departments to cope with, and expand on, their growth. For this reason, they require a complaint specialist to manage their growing demands across this area. This is an exciting challenge to head this function of their business with promotion and management potential.
Independently classify complaint cases & evaluate all incoming customer complaints
Assess complex cases, classify severity, and document the reporting obligation.
Preparation of documents for auditors and PRRC in the quality department
Assist with Audits in relation to complaints
Perform plausibility checks
You will be the responsible person for managing and improving the complaints process
Close collaboration across all departments in their Freiburg based HQ
Open to discuss inclusion of other areas of quality management within your job responsibilities if you desire
Degree in Medical Technology or related.
Ideally from a medical device background
Basic knowledge of ISO 13485:2015 and 93/42/EEC and 2017/745
Knowledge of complaint processing and reporting obligations
German (level B2)
Salary Package: Circa. 55,000 EUR
Fantastic team culture, with an open office for team collaboration
Hybrid working opportunity – 50% from home
JobRad service (Bicycle hire)
Hansefit (€35 per month).
Participation in BAV
Company bonus (discretional based on yearly performance companywide
12 month salary payment
For an informal conversation please get in touch with Alex Coveney-Alym firstname.lastname@example.org