QC - Compliance Manager

Philippsburg  ‐ Vor Ort
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Schlagworte

Beschreibung

Principal Consultant - Senior

Tasks:
* Conception and Implementation of a „Software as a Medical Device (SaMD)" Framework
* Consulting on regulatory requirements, when implementing SaMD projects (standards, security and privacy requirements etc.)
* Consulting on accreditation of SaMD projects
* Review of SaMD project specific deliverables from a regulatory and formal perspective

Requirements:
* Strong analytical skills
* Strong negotiation skills
* Strong expertise in building Quality management system frameworks
* Strong expertise in IEC 623366, IEC 60601, IEC 80001, ISO 13485
* Teamplayer
* Fluent english

Non-Technical profile requirements

* Accepts personal responsibility for client satisfaction

* Strong tracking, coordination and project planning skills

* Establishes and manages engagement objectives, expectations and quality plan

* Ability to identify and implement process and/or application improvements

* Strong analytical and problem-solving skills

* Must be able to work on multiple simultaneous tasks with limited supervision

* Quick learner, motivated self-starter

* Excellent customer service, interpersonal, communication and team collaboration skills

* Able to follow change management procedures and internal guidelines Methodology/Certification requirements

* Master and/or Bachelor Degree in Mathematics, Engineering, Computer Science, Chemistry or Bioinformatics OR equivalent through experience. Advanced course work in technical systems plus continued education in technical disciplines is preferred

* Additional certification is a plus Language proficiencies

* English spoken and written

* German spoken and written

Für mehr Informationen über Real, besuchen Sie www.realstaffing.com
Start
01/2014
Dauer
11 Monate
Von
Real Staffing
Eingestellt
22.01.2014
Projekt-ID:
653997
Vertragsart
Freiberuflich
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