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Compliance Engineer

Job type:
Permanent
Sector:
Engineering
Location:
stuttgart
Salary:
£65000.00 per annum
Date posted:
11/08/2017
Job reference:
BBBH7451_1502463656

Quality Engineer - permanent

Location: Stuttgart

Salary: Up to €65,000 annually

Overview:

Reporting to: Director QA/RA Germany

Key Responsibilities

Key responsibilities will include (but are not limited to) the following:

  • Create validation plans/protocols for manufacturing processes in an GMP environment
  • Apply the GHTF validation guideline
  • Apply technical solutions to problem solving especially for medical devices containing an ancillary medicinal substance within GMP, EMEA and ICH-guidelines
  • Apply technical solutions to quality improvement projects
  • Use technical writing skills to clearly describe technical information
  • Analyze customer complaints, identify trends and execute corrective actions
  • Understand standards and their application to medical devices
  • Planning, protocol generation, testing and report generation for medical devices
  • Generation and maintenance of Technical Files for medical devices
  • Review and update technical files in line with EU medical devices regulatory requirements
  • Ensuring that records are filed in accordance with site procedures.
  • Supporting R&D projects

Key Relationships / Interfaces

  • Senior Engineering Manager
  • Risk Manager, EMEA
  • EMEA QA/RA
  • EMEA Operations
  • EMEA R&D
  • EMEA HQ Support functions
  • Global QA/RA

Essential Skills / Experience

  • Engineering/Science qualification with about 5 years of work experience within R&D/QA/RA in a medical device or pharmaceutical environment.
  • 2/3 years experience in R&D, QA/RA, Process Validations - essential
  • 2/3 years experience in Risk, Clinical and Biocompatibility - an advantage
  • Excellent technical writing experience within a medical device or pharmaceutical environment - essential
  • Attention to detail and accuracy - essential
  • Fluent German and English, both written and oral - essential
  • Ability to work well under deadlines and pressure
  • Problem solving skills for developing creative solutions and meeting objectives are required.
  • Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MD Project, Outlook and Excel);
  • Excellent analytical ability
  • The ability to prioritize tasks and be able to manage several projects and tasks simultaneously; and the ability to interface with all levels of management.

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