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Quality Senior Supervisor

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Wexford
  • Sector: Science
  • Date posted: 28/08/2017
  • Job reference: J367934A
This vacancy has now expired.

Quality Senior Supervisor

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

JOB SUMMARY

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.

RESPONSIBILITIES 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;
  • 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

SKILLS AND KNOWLEDGE:

  • 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.

MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS:

  • 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.