Senior Quality Systems Engineer

3 weeks ago

Limerick, Ireland Real Staffing Full time
Senior Quality Systems Engineer (CR/4000663) Limerick, Republic of Ireland

Salary: EUR60 - EUR60 per hour

Our client is seeking a talented Senior Quality Engineer for their Limerick office. As part of our team, you will play a crucial role in implementing QMS to target ISO13485/MDSAP certification while also leading RCI change control efforts, managing internal audits and performing root cause analysis.

Qualifications:

  • Bachelor's Degree level 7 or higher
  • Minimum 5 years' experience working with quality systems within medical device industry

Main Responsibilities:

  • Actively engage for implementation of the Quality Management System throughout the site, targeting ISO13485 / MDSAP certification
  • Maintain the Quality Manual and Quality Procedures and ensure content is compliant to applicable requirements and helps to maintain business agility.
  • Lead RCI change control activities within the site
  • Analyse current and future procedural needs of the QMS
  • Organise and manage the plant internal audit system and the corrective action reporting system
  • Conduct Quality Systems audits and assist in training/guidance to other auditors
  • Host external/internal Quality System audits
  • Provide training on Quality best practices and QMS processes
  • Coordinate the review of Quality procedures associated with plant continuous improvement initiatives
  • Develop quality training program as per site needs
  • Coordinate quality data consolidation and reporting on Key Performance Indicators (KPIs) in order to drive continuous improvement across QMS.
  • Analyse current and future procedural needs of the business
  • Plan Standard Operating practices required under the overriding Quality procedures
  • Maintain the Standard Operating Procedure content and coordinate the issuing of these documents
  • Support other functional areas of the business including engineering, design
  • Collate quality data for monitoring targets
  • Assist with training of quality awareness
  • Report on Key Performance Indicators (KPIs) in order to adhere to process and prevent occurrence of any non-conformity relating to product, process or system
  • Promote the use of customer preferred techniques for continuous improvement such as Six-Sigma, Poka-Yoke (Error Proofing), and Measurement System Analysis
  • Keep up with current and developing design and engineering trends that concern product quality
  • Undertake special projects as required
  • Contribute to continuous improvement activities
  • Plan projects or subtasks so they may be tracked and presented
  • Attend various meetings and action/communicate instructions
  • Undertake continuous training and development
  • Perform root cause analysis and resolve problems
  • Independently determine approach and assigned tasks

Sector: Medical Devices

The ideal candidate should possess extensive exposure towards handling different types of equipment used throughout healthcare settings including diagnostic imaging machines, surgical instruments, implantable devices among others.

If interested please apply by sending us your resume today

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