Quality Expert Medical Devices (m/f)

REFERENZNUMMER:

288621/11

IHRE AUFGABEN:

-Manage projects and/or processes (focus on parenteral, e.g. syringes, pre-filled syringes, autoinjector), and allocated resources to support departmental projects and objectives according to agreed timelines and standards, and assure compliance with GMP is maintained in TRD
-Contribute to implementation of ISO13485 standard in client's QMS
-Approval of development-relevant documents and decision making acc. to internal SOP-5003834 (Global TRD Approval and Release Authorities) with the authority of QA Manager, with the authority of QA Diagnostic peritoneal lavage (DPL) and with authorities delegated by Head of Global QA Project Management
-Support authority in the release of medical devices
-Establishment and maintenance of QA processes for device development
-Assessment and review of GMP quality manual modules
-Initiate/lead/contribute to interface meetings with Device Development line units to handle and follow-up on general GMP-relevant topics for continual improvement of processes
-Represent technical research development QA globally as specialist for Device Development in corresponding teams
-Guide TRD sub-teams in PAI preparation
-Support medical device and combination product development and/or life cycle management by providing expertise, procedures and processes

IHRE QUALIFIKATIONEN:

-Basic degree in scientific or relevant discipline, desirable is a advanced degree in a scientific or other relevant discipline (MSc or equivalent)
-Fluency in English (oral and written) required, fluency in German desirable
-Profound relevant experience, ideally with focus on parenteral, e.g. syringes, pre-filled syringes, autoinjector
-Sound scientific, technical and regulatory knowledge in a specific area , mainly development, filing, transfer to production
-Excellent knowledge of cGMP, working knowledge of medical device regulations, standards and guidelines
-Good knowledge regarding medical device development
-Good and demonstrated ability to analyse and evaluate GMP compliance

WEITERE QUALIFIKATIONEN:

Quality manager