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Search Results for Quality Systems Engineer
Job Title. Location Salary Actions

Commissioning Qualification Validation (CQV) Engineer

CQV Engineer, Cork (Contract) Life Science Recruitment is looking for a CQV Engineer to join one of their respected clients in Cork. Experience in the pharmaceutical, medical deviceor biotechnologyindustries is required and a distinct advantage. Role Overview: The Commissioning, Qualification and Validation (CQV) Engineer will provide CQV services to clients in the Life Sciences Industry. This position shall be responsible for the development and execution of CQV documentation on a variety of equipment, facilities, utilit...

Location: Cork,
Commissioning Qualification Validation (CQV) Engineer
Cork Not Disclosed

Quality Specialist (Medical Devices)

12 Month Fixed Term Role JOB SCOPE: Reporting to the Quality System Manager you will join a team responsible for improving key Quality System processes including Internal Auditing, NCEs, DCOs, Batchcard / Release sheet review and internal training to staff and operators on quality issues. Provide QA support to manufacturing operations as required. Participate in projects in order to contribute to continuous improvements. This role will involve liaising with cross functional teams on driving improvement and streamlining of the assigned processes. KEY RESPONSIBILITIES: T...

Location: Cork,
Quality Specialist (Medical Devices)
Cork €40000 - €45000

Quality Systems Engineer Career Profile

Quality Systems Engineer


A Quality System is responsible for the design, implantation and maintenance of Quality Systems in a medical device company.

Role/Responsibilities

  • Quality System compliance to ISO9001, ISO13485 and Medical Devices Directive
  • Represent EMEA on global quality initiatives
  • Liaise with EMEA manufacturing sites and subcontractors
  • Drive and implement Quality System Improvements Perform audits of subcontractors
  • Perform internal audits
  • Support external audits
  • Manage CAPA and Event Investigations for site

Skills/Experience

  • Engineer/Science qualification with minimum of 8 years working within QA/RA in a multi-national Medical Devices environment
  • Attention to detail and accuracy - 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
  • Communication skills
  • 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.