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Niamh Hlubek
Life Science

+353 87 114 6347
[email protected]
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Details

Quality Engineer Production Support Onsite


Reference:NHL/ADIN-108353 Location: Kildare
Qualification:DegreeExperience:1-2 Years
Job Type:PermanentSalary: €50000 - €55000
May be suitable for: Quality Engineer

NHL/ADIN-108353 Quality Engineer- Production support onsite role

To assist the Quality Manager in the implementation of the Quality ManagementSystem. Support the overall quality team onsite.

RESPONSIBILITIES:


The Quality Engineer (QE) shall be responsible for monitoring the production and release of finished parts and ensuring quality policies and procedures are adhered to on a daily basis, in accordance with the requirements of the Quality Management System. This includes but is not limited to:

  • Responsibility for production GMP standards
  • Investigation of root cause and following through on effective corrective actions to prevent re occurrence for customer and internal quality issues.
  • Initiating and completing CAPA actions as required.
  • Initiating and completing engineering change request and action as required.
  • Initiating and completing non-conformance reports (NCR’s) as required, coordinating product/production related NCR’s to closure in a timely manner.
  • Establishing and monitoring inspection standards, plans, frequencies and test methods.
  • Establishing and maintaining FMEA’s.
  • Preparing and updating quality system documentation
  • Supporting customer and surveillance accreditation audits.
  • The quality engineer will perform an active role in quality planning and new product introduction from a quality perspective.
  • Have a good working knowledge of quality management systems (Ideally
  • ISO13485) and other product related regulatory requirements
  • Develop strong links with customer organisation’s and other project stakeholders.
  • Validation experience would be advantageous.
  • Performing an active role in further development and continuous improvement of the quality management system.
  • Support Operations area projects and initiatives.
  • The training of new or existing personnel on quality procedures and documentation; ensuring that production personnel are trained for their tasks and that procedures are in place.
  • Understanding of customer documents i.e. Drawings, Purchase Specification, Quality Agreements etc
  • Ensuring that on hold material is dispositioned and actioned from QAHOLD in a timely manner.
  • Ensuring that all retained samples are stored correctly, and that sample storage area is maintained.
  • Ensuring that all quality records are completed as per the company procedure comply with GDP.
  • Adherence to incoming control requirements and supporting the SCAR process when required.
  • Audit experience advantageous.
  • Perform additional duties at the request of the Quality Manager.

The Ideal Candidate will:
  • Hold a relevant 3rd level qualification and/or equivalent quality experience (1+ yrs @ similar level) ideally in high volume manufacturing.
  • Have good communication and interpersonal skills
  • Be a team player with the ability to work independently. Be proactive and solutions driven in their approach.
Any applicant must have an existing work permit / visa to apply for this role and be able to work 5 days a week onsite in Kildare.