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Engineering & Technical

Job Description

A Quality Systems Engineer is required by CareerWise Recruitment for our Westmeath based client. Reporting to the Quality Systems Manager, you will be responsible for providing quality systems support for to all processes related to QMS. Assure that the quality standards are maintained and assist with the implementation and compliance of the quality management program. Support company goals and objectives, policies and procedures, quality systems, and FDA regulations. Please contactTom Devaney for more information.

Role of this position

Document Control
  • Manage all controlled documentation in all its media variants.
  • Create and maintain Controlled Document Stations (CDS) as appropriate including suppliers as necessary.
  • Ensure distribution of specification to suppliers is maintained.
  • Create user accounts and provide rights / roles accordingly for company personnel, as appropriate.
  • Liaise with disposables team to ensure all relevant documents, various media, is compliant.

Change Control System
  • Manage change control system through Smart.solve.
  • Train personnel on change order process.
  • Assist personnel with creating and/or processing change orders, including the completion of risk assessment and validation requirements.
  • Tracking and management of Ireland generated change orders.
  • Generate management metrics on change order system.

Internal Audits
  • Working in coordination with the Quality Systems Manager to prepare, maintain and execute the annual local audit schedule and any subsequent revisions.
  • Reviewing and approving the results of internal audits conducted in accordance to this procedure.
  • Informing Management about the Internal Audit process effectiveness.
  • Closing the audit.
  • Maintaining the audit and Auditors training files.
  • Preparing Metrics on Internal Audits.
  • Coordinating Internal Audit review meetings.

JOB REQUIREMENTS

  • Bachelors Degree (LEVEL 8) in Engineering, Science or related subject.
  • A minimum of 5 years industry experience. Medical Device experience strongly preferred.
  • Excellent Communication Skills
  • Experience in working in High Volume Production Facility
  • Strong computer skills
  • Strong document management skills
  • Familiarity with ISO quality systems (ISO9001, ISO14001 and/or ISO13485)
  • Good customer relation skills
  • Ability to present an independent opinion
  • Good Presentation skills

Please call Tom Devaney today for further information on 091-758771 or email: tdevaney@careerwise.ie
CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

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Engineering & Technical

Cork Office

CareerWise Recruitment. EastGate Village, EastGate, Little Island, Cork.

Phone: +353 (0) 21 206 1900

Email: info@careerwise.ie