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Engineering & Technical

Job Description

Opportunity for a QUALITY SYSTEMS SPECIALIST / QUALITY ENGINEER to join our medical device (eye health) clients European Quality Systems team in Dublin, initial 12 month contract on offer. The QUALITY SYSTEMS SPECIALIST / QUALITY ENGINEER will be responsible for maintaining the Quality Management System and providing guidance to the EMEA region on quality system issues.

Role of this position

  • Execute and document non-conformances, Corrective Action requests and Corrective and Preventative Actions and report on these metrics at Quality System management reviews
  • Define and lead actions related to change requests
  • Support and document internal audits for compliance to regulations, agreements, standards and documented processes, of Market Companies and Distribution Centres.
  • Guide the development of and improve comprehensive measurement systems for quality performance.
  • Ensure systems to measure, assess risk and escalate quality events.
  • Manage quality events to identify, bracket, correct, control and prevent defects.
  • Lead and document internal quality procedure change efforts.
  • Participate in quality system improvement initiatives.
  • Support the training program of the region.
  • Create Quality Management Reviews, in alignment with the business
  • Support the coordination of field actions and escalations
  • Perform and document Economic Operator Verification under EU-MDR.

JOB REQUIREMENTS

  • You will be degree qualified, preferably a science degree, with experience of working in a regulated environment.
  • At least 3-5 years in Quality Assurance in another function in the medical device, pharmaceutical or related industry experience.
  • You will have wide Quality Engineering experience and be able to work effectively across many different functions internally and externally which will ensure that we meet both the customer and the business needs.
  • You will have a strong sense of personal responsibility and be able to work both as an individual leader and be a strong team player.
  • Continuous improvement will be at the heart of your decision making, looking for areas in which we can create efficiencies through better working practices to deliver enhanced compliance.
  • You'll conduct day-to-day and strategic activities in supplier lifecycle management, meaning you will be great at establishing clear expectations and collaborating with internal and external partners leading to consistent, reliable processes and services.
  • Exceptional communication skills to allow you to work effectively across various levels and teams
  • A passion for continuous improvement
  • Lead Auditor training (ISO13485) - Desirable but not essential.

Please call Conor Twomey today for further information on 087-0907204 or email: ctwomey@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