Quality Manager Audit and Supplier

Deutschland  ‐ Vor Ort
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Beschreibung

Quality Manager Audit & Supplier- Germany

One of the largest healthcare organisations in the world is currently in need of a Medical Device Quality Audit & Supplier Manager to step in for a fixed term temporary assignment in the greater Munich area, Germany. This is a fantastic opportunity for a seasoned Medical Device/Combination Products professional to impact the technical development and quality practices in a highly innovative environment.

The Role:
  • Ensure successful inspections and audits outcome at the sites involved in Medical Device manufacturing, testing and assembly. Ensure sites are achieving and continuously operating under an inspection-ready state for partner audit and regulatory inspections.
  • Coordination Interface to all assigned Medical Device Suppliers.
  • Creation and control of the auditing plan for MD suppliers for BTDM.
  • Coordination and execution of audits and audit follow up's of external suppliers to ensure product specific focus and coverage.
  • Coordination and preparation of QA Agreements with MD suppliers.
  • Creation and evaluation of data for monthly KPI trending and reporting.
  • Support of customer and health authority inspections.
  • Securing of the GMP compliance of suppliers.
  • Management of Supplier issues e.g. Deviations and other operational tasks like Change Controls.


Your Profile:
  • Fluency in Spoken and Written English
  • At least 3 years of relevant experience
  • Ability to influence people, negotiate and communicate.
  • Sound scientific, technical and regulatory knowledge in a specific area.
  • Experiences with health authority inspections and customer audits
  • Good knowledge of cGMP, working knowledge of medical device and combination product regulations, standards and guidelines.
  • Good knowledge of medical device development and life cycle management.
  • Excellent organizational skills
  • Good and proven ability to analyse and evaluate GMP compliance.


Desired Skills:
  • French and/or German Skills


Should you match the above requirements, please submit and updated version of your CV and we will be in contact shortly.

Key Words: GMP, GxP, QA, Change Controls, Supplier, Deviation, Deviation Management, Audit,Medical Device, Med Dev, QA, QMS, Combination Products, cGMP, Risk Management, Quality, SOP, Regulatory, Regulatory CGMP, ISO 13485, English, French, German

Mehr Informationen über Real Staffing erhalten Sie unter www.realstaffing.com/de
Start
08/2016
Von
Real Staffing
Eingestellt
25.07.2016
Projekt-ID:
1173257
Vertragsart
Freiberuflich
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