Connecting...

Senior Quality Engineer - Startup

Job description

Responsibilities

  • Responsible for compliance with Quality policies, procedures and international regulations whil also leading improvement activities in line with internal quality system.
  • Plan, execute, report and follow-up on quality system audits. Act as an audit escort and/or support in the coordination of backroom activity during inspections as required.
  • Preperation of reports for production, enviornmnetal monitoring, vendor assessments, NCRs , CAPAs and supplier corrective actions.
  • Deal with quality matters in relation to agencies, vendors and regulators.
  • Implemnet, develop and improve quality tools in relation to risk management, risk management, dFMECA, pFMECA and associated reports.
  • Assist department and project leaders in developing and reporting appropriate performance and quality metrics.

Requirements

  • Bachelors degree in engineering, science or related field with 5 years or more in QA, QMS or regulatory affairs.
  • Knowledge of FDA’s 21 CFR Part 820 (Quality System Regulation), ISO 13485:2016, the European Medical Device Directive, and the Canadian Medical Device Regulations.

If you need any additional information, please feel free to contact jporter@sigmar.ie or call 091455305 for a quick discussion about this role. All applications are treated with the utmost discretion.

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.