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Collins McNicholas

Quality Systems Engineer vacancy with a midlands based Medical Device company. 

Quality Systems Engineer

Key Responsibilities

  • Quality Assurance responsibility for document change control, complaints & CAPA management within the organization.
  • Maintain these Quality Management System processes in line company procedures.
  • Liaise with internal customers to support quality assurance activities.
  • Responsible for customer complaint handling and maintenance of the customer complaint handling system including the implementation and follow up of corrective actions.
  • Monitor investigation timelines for quality issues e.g. non-conformance and CAPA and productivity initiatives associated with operations.
  • Provides guidance in the resolution of complaint investigations including guidance on correct administration.
  • Provides guidance on correct administration for document changes or design changes.
  • Provide training on complaints administration where required.
  • Update governing quality procedures to ensure compliance with quality system needs and relay this information where required.
  • Report out key process indicators (Document Change Control, Complaints & CAPA) on time on an on-going basis.
  • Support the implementation of an Electronic QMS for the organisation, specifically in relation to document control, training and corrective action management.
  • Support preparations for external audits and
  • Take on any further reasonable responsibilities as assigned to you by your manager.

Person Profile

  • Certificate or Diploma (Science / Engineering) qualified with a minimum of 2 year’s industry experience.
  • Experience within the Medical Device or Pharmaceutical Sector.
  • Must to competent in Ms Word, Excel, PowerPoint and other software systems.
  • Ability to work independently and also as a team member, to multi-task and prioritise to meet high expectations and tight deadlines.
  • Attention to detail is key including good documentation practices and process adherence.
  • Maintain a level of thoroughness within the working materials whilst carrying out daily duties.
  • Good technical capabilities, communication skills, teamwork abilities and initiative.
  • Fully motivated to achieve and demonstrate best practices in line with the project, department and site objectives.
  • Willingness to develop excellent analytical and problem solving abilities.
  • Willingness to develop academically and be ambitious to succeed within the Organization.
  • Must be available to travel on requirement.

 Experience and Capabilities

  • Experience of ISO13485 is desirable
  • Experience of Quality System Regulations to 21 CFR Part 820 would be an advantage
  • Auditing experience would be an advantage.

For a confidential discussion and more information on the role, please contact David Lennon on 09064 78104 and email your CV to

For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website

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