QA Specialist - Medical Devices

Highly Competitive
  1. Permanent
  2. Good Manufacturing Practice (GMP)
  3. Iceland
Reykjavík, Iceland
Posting date: 20 Jul 2020
30688

An exciting opportunity has arisen for a QA Specialist to focus specifically on Medical Devices. The role based in Iceland is great chance to build your portfolio with a leading pharmaceutical company.

Job Responsibilities

  • Drive simplification & standardization of the QMS in line with overall quality strategies & initiatives
  • Establish international and regional /local relationships with RA, other QA Groups, Manufacturing, Development and Management
  • Ensure continuous regulatory knowledge as necessary for the business.
  • Host and manage site audits
  • Manage relationship with health authorities
  • Maintain oversight of customer feedback and post marketing activities (e.g. complaints, FSCAs, recalls)
  • Maintain oversight of supplier monitoring program
  • Perform internal and external audits
  • Maintain oversight of training program
  • Record and manage quality issues, escalating serious events to senior management
  • Lead Medical Device management review process and quality planning
  • Lead and/or participate in quality/compliance/regulatory projects

Skills and Requirements

  • Bachelor's Degree education in Pharmaceuticals, Law, Bioscience, Engineering or Business or equivalent field coupled with relevant business experience in Quality/Regulatory leadership roles.
  • 5 years experienced working with EU, FDA, ISO 13485, ISO 14971 and other global Medical Device regulations
  • Strong collaboration skills and ability to build partnerships internally and externally
  • Experience of working directly with competent authorities
  • Change management experience and influencing skills
  • Track record of leading teams and driving results

To Apply

In case you have difficulty in applying or if you have any questions, please contact Katty Maia on +44 203 854 3317 or upload your CV on our website - www.proclinical.com/send-cv

A full job description is available on request.

#LI-KB1

#QualityAssurance

close