Quality and Regulatory Officer ISO 13485

Recruiter
Focus Resourcing
Location
Caerphilly
Salary
37000.0000
Posted
06 May 2017
Closes
05 Jun 2017
Sector
Engineering
Contract Type
Permanent
Hours
Full Time

Our client is looking for a Quality and Regulatory Officer to join their team. The role will report into the Head of Regulatory Affairs.

Responsibilities:

  • To act as ISO Quality system representative to ensure compliance with ISO 13485 and ISO 9001 systems in conjunction with QEHS Department
  • To perform internal and external auditing as assigned in annual schedule including to ISO 9001, 13485 requirements
  • Assistance with Group UK's ISO 13485 quality management system including monitoring, developing, reviewing and seeking approval for continuous improvements in ISO quality assurance policies and standard operating procedures
  • Manage and optimise activities in line with the chosen strategy, regulatory requirements and agreed financial targets and resources
  • Manage and maintain good professional working relationships both internally and externally
  • Reporting to management on the performance of the quality management system and any need for improvement
  • Ensuring the promotion and awareness of customer requirements throughout the organisation

Essential Skills:

  • Experience of working in an ISO 9001:2008 environment and ISO 13485:2015
  • Experience of auditing to ISO 9001 and/or ISO 13485
  • Lead Auditor qualification in quality assurance desirable
  • Experience of regulatory body liaison e.g. the MHRA/HPRA/FDA
  • Proven ability to work as part of a multi-functional team
  • Highly effective problem solver, excellent communicator, both verbal and written
  • QMS software systems experience

Company offer an excellent working environment, good benefit package and career progression.