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Quality Senior Supervisor

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Wexford
  • Sector: Science
  • Date posted: 28/08/2017
  • Job reference: J367934A

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Quality Senior Supervisor

Location: South Ireland
Job Type: Perm
Salary: Neg.


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


  • Developing and maintaining quality world class systems related to the manufacture of guide wires while developing employee efficiencies,
  • Direction for quality in all manufacturing areas, namely;
  • Direction of the relevant inspectors in areas of responsibility
    • Areas for Improvement to management.
    • Coating
    • Grinding
    • Coil Winding.
    • High & Low Volume Assembly
    • Interventional
    • Cleanroom & Bulk Packaging
    • Shipping.
  • Direction of the relevant quality engineers in areas of responsibility
  • Playing a role in the plant annual objectives.
  • Ensure continued compliance with all Regulatory Standards including:
    • 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.
    • 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 for areas 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:
    1. Participation in validation protocol development
    2. Overseeing completion of validation or validation samples
    3. Supporting the manufacturing engineering function to ensure compliance to related element of quality system.
  • Carry out a documented monthly evaluation with the quality engineers as well as an annual review.
  • Ensure open communication exists between the quality engineers and all other groups in order to facilitate the speedy dissemination of relevant changes and improvements to both products and processes.
  • Supervision of quality engineers to ensure compliance for their areas of responsibility for
    • implemented process controls,
    • 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.
  • Ensuring information for PMR and Management Review meetings is maintained and available on time.
  • Manage and minute PMR KPI meetings
  • Maintain training records for all reports
  • Ensuring all quality reports are of required standard and issued on time.
  • Maintain Core records for all direct reports and raise issues concerning timekeeping should they occur


  • 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.


  • Engineering or science Degree preferably with Quality Engineering included.
  • 5 years medical device experience desirable
  • Previous supervisory experience essential

PLEASE NOTE: Candidates must have full working rights in Ireland i.e. (a current Stamp 4 Visa or an EU Passport to be eligible to work in Ireland) to be considered for this role.

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