Leading Quality Expert

2 days ago

Galway, Galway, Ireland beBeeSenior Full time €75,000 - €90,000
Job Opportunity: Senior Quality Systems Engineer

Role: We are seeking a highly skilled Senior Quality Systems Engineer to play a key role in the set up, implementation and maintenance of our company's Quality Management System. This is an exciting opportunity for you to work as part of a supportive, collaborative team in a state-of-the-art facility.

This position will involve ensuring that our quality systems are compliant with relevant regulatory requirements, including the Medical Device Directive 93/42/EEC, Medical Device Directive 2007/47/EC, Medical Device Regulation 2017/745, FDA Quality System Regulations 21 CFR § 820 & 803, ISO 13485, and ISO 14971. You will also be responsible for maintaining and continuously improving our quality management systems, coordinating CAPA, complaints, and temporary authorization processes, reviewing and approving non-conformance reports, and managing audit actions from initiation to closure.

The ideal candidate will have a minimum Diploma level education in an Engineering, Science, or Quality Assurance discipline, with training or qualification in quality systems, complaints, and CAPA being highly desirable. A minimum of five years' experience in the medical device industry is required, with familiarity of ISO13485, ISO14971, Medical Device Regulation 2017/745, and FDA QSRs also essential. Experience in managing quality systems activities, particularly complaints and CAPA, is desirable.

  • Ensure compliance with Medical Device Directives and Regulations
  • Maintain and improve quality management systems
  • Coordinate CAPA, Complaints, and Temporary Authorization processes
  • Review and approve non-conformance reports
  • Manage audit actions from initiation to closure

Benefits: Our company offers a competitive salary, hybrid working arrangements, bonus scheme, pension plan, and share options. If you are looking for a challenging and rewarding career opportunity in a dynamic and supportive environment, please apply now.

Responsibilities:

Strategic planning and implementation of quality management systemsQuality system audits and assessmentsComplaint and non-conformance investigationsDevelopment and implementation of corrective action plansCollaboration with cross-functional teams to drive business objectives

Requirements:

Minimum Diploma level education in Engineering, Science, or Quality AssuranceTraining or qualification in quality systems, complaints, and CAPA5+ years' experience in medical device industryISO13485, ISO14971, Medical Device Regulation 2017/745, and FDA QSRs knowledgeQuality systems management experience

How to Apply: To apply for this exciting opportunity, please contact us using the details below. Don't miss out on this chance to join our team and take your career to the next level

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