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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 david.lennon@collinsmcnicholas.ie

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 www.collinsmcnicholas.ie

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