Senior Quality Engineer

  • Reference: CJ46301
  • Job Type: Permanent
  • Location: Cork, Cork City, Munster
  • Category: Engineering, Technical & Manufacturing

Role Summary:

The Senior Quality Engineer will primarily be responsible for maintaining and improving where necessary all quality systems and monitoring production process for compliance to implemented process controls.

Role Duties:

  • Developing and maintaining quality world class systems related to the manufacture of guide wires while developing employee efficiencies,
  • Direction for quality in two product manufacturing areas
  • The co-ordination and control of one of the key components of the LRI quality system.
  • Direction of the relevant inspectors in area of responsibility
  • Direction of the relevant quality engineers in area of responsibility
  • Playing a role in the plant annual objectives.
  • Ensure continued compliance with all Regulatory Standards. This includes:
    • ISO 13485
    • FDA QSR
    • ISO 14000
    • Ensuring continued compliance with DMR
  • Monitor production process for compliance to implemented process controls to ensure quality product is shipped to customer and provide:
    • Trend analysis of data from the controls
    • Potential improvements for review with engineering based on the trends.
    •   Areas for Improvement to senior management.
    • Review and propose changes to sampling plans based on trend analysis and

changes to the system.

  • Support the RCA meetings to ensure that internal and customer concerns are handled and dealt with in an appropriate manner.
  • Review and ensure that area of responsibility (and those of direct reports) documents listed below are approved in an appropriate and timely manner
    • Validations
    • Engineering Change Order (ECO).
    • Request for Corrective Action (RCA).
    • Request for Technical assistance (RTA)
    • Material Review Request (MRR).
    • Internal Audits.
    • Failure Mode Effect Analysis (FMEA).
    • Variation Permits (VP).
  • Develop and maintain a program ensuring only correctly validated equipment is used in production process. This will include:
    • Participation in validation protocol development
    • Overseeing completion of validation or validation samples
    • Supporting the manufacturing engineering function to ensure compliance to related element of quality system.
    • Assuring product quality
    • Qualification and validation
    • Quality direction for RCAs, RTAs, technical issues related to regulatory queries
  • Project meeting attendance as required.
  • Attend and participate in daily cell meetings.
  • Preparation of information for PMR and Management Review meetings.


Skills Required:

  • Ability to communicate and work with people inside and outside the department.
  • Good communicator (written and oral).
  • Ability to train and lead.
  • Ability to co-ordinate, plan and organise in a timely manner.
  • Knowledge of engineering theories and methods.
  • Good technical report writing skills.
  • Rigorous attention to detail.


Education and Experience Requirements:


  • Engineering or science Degree preferably with Quality Engineering included.
  • Minimum 5 years’ experience within a regulated environment


For a confidential discussion and more information on the role, please contact Eloísa Ruiz on 021 4911066 or email

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Eloísa Ruiz

Contact Consultant

  • Eloísa Ruiz
  • Recruitment Consultant
  • 021 4809 118
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