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Senior Quality Supervisor

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Wexford
  • Sector: Science
  • Date posted: 12/01/2018
  • Job reference: J379929A

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Our client, a global leader in the manufacturing of medical devices based in Wexford, has a requirement for a Quality Senior Supervisor to join their growing team.

The Senior Quality Supervisor will primarily be responsible for supporting a Value team and will have a number of Engineers and Inspectors reporting to them.

Accountabilities include:

- 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:

o Coating

o Grinding

o Coil Winding

o High & Low Volume Assembly

o Interventional

o Cleanroom & Bulk Packaging

o Shipping

- Direction of the relevant quality engineers in areas of responsibility

- Direction of the relevant inspectors in areas of responsibility

- Playing a role in the plant annual objectives.

- Ensure continued compliance with all Regulatory Standards including:

o ISO 13485


o ISO 14000

o Ensuring continued compliance with DMR

- Monitor production process for compliance to implemented process controls to ensure quality product is shipped to customer and provide:

o Trend analysis of data from the controls

o Potential improvements for review with engineering based on the trends.

o Areas for Improvement to management.

o 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:

o Validations

o Engineering Change Order (ECO).

o Request for Corrective Action (RCA).

o Request for Technical assistance (RTA)

o Material Review Request (MRR).

o Internal Audits.

o Failure Mode Effect Analysis (FMEA).

o 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.

- Supervision of quality engineers to ensure compliance for their areas of responsibility for

o Implemented process controls,

o Assuring product quality,

o Qualification and validation

o 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

- 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.


 - 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

 - Supervisory Experience essential


For a more detailed role description or information on other positions, please contact Kathryn on 01-6455244 / 087 3555378

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