Specialist Documentation

Switzerland  ‐ Onsite
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Description

Documentation Specialist (Medical Devices)

For my client, based in the Canton of Zürich I am currently looking for a Specialist for Document Control.

The company is the world leader in mechanical Implantable devices, well known for their innovative work climate and their unique products.

The Documentation Specialist conforms to company standards and coordinates change control process. Maintain the archival of quality records and laboratory notebooks. Coordinate training requirements of new and revised procedures with process owners and interface with electronic training system to launch training. The Documentation Specialist will also prepare meetings for Doc Control.

Main Responsibilities:
  • Independently working on Quality and Technical Documentation Projects
  • Develops optimal methods for achieving goals within Quality Projects
  • Supports audit activities, creates and reviews new processes and procedures
  • Responsibilities include the following Documentation:
  • Quality Documents, Change Requests and Product Information
  • Other Project Responsibilities: Leads and manages various documentation and change projects
  • Plan, execute and lead projects as assigned
  • Training of new employees to new or established Document Control related projects
  • Serve as a technical advisor
  • Quality Responsibilities: Insure conformity in the Quality System
  • Identify Quality improvements and develop suitable corrective actions (CAPAS)
  • Implement Quality improvement projects and other job duties as assigned.
  • Supports and performs training of quality procedures


Qualifications:
  • Bachelor or similar degree in Engineering or a related discipline
  • 3-5 years of experience in Regulated Industry ideally in the Medical Device field
  • Experience in coordinating of cross functional Projects
  • 2-3 years of experience in Quality Control; Document Control; Compliance; Auditing; or Regulatory
  • Experience as a Subject Matter Expert in the field of Document and Change Control.
  • Flexible and outgoing personality who is able to Drive and/or support Quality Projects and Stakeholders
  • Handles all tasks efficiently. Applies functional knowledge to the introduction of new processes
  • Knowledges of ISO 9001, ISO 13485 or 21CFR820


Should you be interested in this or similar position, please feel free to get in contact with me:

Consultant Details:

Sabina Keel

T:

E:

Sthree Switzerland is acting as an Employment Business in relation to this vacancy.
Start date
05/2018
Duration
24 months
From
Real Staffing
Published at
14.06.2018
Project ID:
1573091
Contract type
Freelance
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