CSV Engineer- Sligo

  • Reference: SJ45815y
  • Job Type: Contract
  • Location: Leitrim, Mayo, Sligo
  • Category: Engineering, Technical & Manufacturing

Senior CSV Engineer- Sligo 

Senior Computer Systems Validation Engineer required in Sligo within the Medical Device Manufacturing sector. Excellent future prospects with this role. Experienced individual required. 

 

Key Responsibilities

  • Coordinating appropriate assigned elements of the Quality System, ensuring full compliance by all relevant plant personnel with its requirements.
  • Coordination and active participation in the validation and quality assurance of site equipment, utilities, processes and software in compliance with company policies, FDA, European cGMP and GAMP standards.
  • Ensure all Computerized systems are qualified in compliance with Data Integrity policies and regulatory requirements.
  • Audit the quality system with other personnel where required.
  • Assist in the investigation and coordination of customer complaints and assess need for implementation of effective corrective or preventive actions.
  • Manage day-to-day CAPA requirements by ensuring timely and effective initiation, investigation, and verification of corrective and preventative actions.
  • Measure performance of the Quality System and providing metrics, for inclusion in the management review, monthly reports etc.
  • Ensure all plant personnel are fully aware of quality requirements (where relevant) by providing the necessary training.
  • Ensure Management is kept informed of all system failures to ensure corrective/preventive action and product containment is taken where necessary.
  • Ensure implementation and compliance with relevant Regulatory requirements.
  • Ensure Quality System Documentation is thorough, complete and compliant. 
  • Ensure compliance to training is maintained.
  • Review Lot Records, ensuring documentation is compliant to requirements and complete lot release for shipment.
  • Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems at the site. 

 

Requirements:

  • 3 year plus experience in the day-to-day operation of the quality system in a highly regulated combination product/device manufacturing environment.
  • Minimum 2 years working knowledge of quality systems regulations (ISO13485/ISO9000; CFR 21 Part 820) or individual elements within the regulations such as; process validation, design controls, CAPA, auditing, etc., is desirable.
  • Experience in an injection moulding or tooling environment is desirable.

 

More detailed job spec available upon request. 

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For a confidential discussion and more information on the role, please contact Davin Ferguson on 0719140251 or email davin.ferguson@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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Davin Ferguson

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  • Davin Ferguson
  • Senior Recruitment Consultant
  • 071 9140251
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