- Reference: CJ44806yy
- Job Type: Permanent
- Location: Munster, Waterford
- Category: Engineering, Technical & Manufacturing
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;
o Coil Winding.
o High & Low Volume Assembly
o Cleanroom & Bulk Packaging
o 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 FDA QSR
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
o 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 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:
o Participation in validation protocol development
o Overseeing completion of validation or validation samples
o 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.
Qualifications & Experience
• Engineering or science Degree preferably with Quality Engineering included.
• 5 years medical device experience desirable
• Previous supervisory experience essential
• 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.
For a confidential discussion and more information on the role, please contact Aisling Lane on 021 4809118 or email email@example.com
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