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Quality Manager

  • Sector: Engineering
  • Contact Email:
  • Job Ref: 22774

Our client a well funded start up based here in Galway are looking to hire a Quality Manager as theycontinue to expand operations.

The Role:

As the Quality Manager, you will play a pivotal role in establishing and maintaining a robust Quality Management System (QMS) in compliance with EN ISO13485:2016, EU MDR and 21 CFR Part 820 regulations. You will oversee various quality assurance and regulatory activities, ensuring adherence to organisational and external requirements throughout the product lifecycle.


  • Lead the development and maintenance of the Quality Management System (QMS) according to EN ISO13485:2016, EU MDR and 21 CFR Part 820.

  • Manage non-conformance and Corrective and Preventive Action (CAPA) processes, including containment, root cause analysis, and product disposition.

  • Drive improvements to the quality system that ensures its suitability, adequacy, and effectiveness.

  • Management of Design History File (DHF) and Device Master Record (DMR) in accordance with US and European regulatory requirements.

  • Provide design assurance oversight and active participant in all stages of design development, testing and design control activities, ensuring quality assurance considerations and requirements met.

  • Provide support to R&D, clinical, and manufacturing development activities.

  • Ensure compliance with all organisational and external regulatory requirements.

  • Plan, execute, report, and follow-up on subcontractor and supplier audits.

  • Document and implement design and process validations in accordance with industry standards.

  • Collaborate with other departments to streamline product approval and manufacturing processes.

  • Facilitate supplier correspondence for key projects and drive quality improvements.

  • Provide QA support in the review and approval of plant related validation protocols, reports, and change requests

  • Oversight and responsibility to ensure site maintains adherence to Quality KPIs performance indicators

  • Develop and implement continuous improvement programs in collaboration with Operations and R&D functions.

  • Act as the lead complaint coordinator and oversee complaint handling processes.

  • Provide technical support to project teams during process development, transfer, validations, and product commercialisation.


  • Bachelor's degree in an engineering discipline.

  • Minimum of 5-7 years of experience in quality management within the medical device industry.

  • Ability to lead the quality team and drive a culture of quality within the organisation

  • Strong knowledge of EN ISO13485:2016 and 21 CFR Part 820 regulations.

  • Proven track record in managing non-conformances, CAPA, and root cause analysis.

  • Experience in supplier management, auditing, and quality systems implementation.

  • Excellent communication and interpersonal skills; ability to collaborate effectively across departments.

  • Strong problem-solving skills with a proactive approach to quality improvement.

  • Detail-oriented with a focus on documentation and compliance.

  • Ability to thrive in a fast-paced, dynamic startup environment.


  • Experience with the preparation of FDA, CE, Ethical Committee, and Competent Authority file submissions.

  • Experience with event reporting during clinical trials.

  • Entrepreneurial spirit with a positive can do attitude.


  • Competitive salary and benefits package

  • Flexible and Hybrid working solutions

  • New office fit out with modern and well-appointed offices

  • Opportunity to work in a well-funded scaling Start up

  • Opportunity to work with a passionate team in a cutting-edge field.

For more information and a confidential discussion on the role please contact Michelle Mc Inerney.

091 706717