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Our client, an innovative and fast-growing medical device company based in Galway, is seeking a Quality Manager to join their expanding team. The company is currently transitioning from development to commercialization and is focused on delivering meaningful, patient-centered solutions in a dynamic and highly regulated environment. This is an exciting opportunity for a quality professional who thrives in a collaborative start-up culture. The successful candidate will play a key role in leading the quality function and shaping the company’s quality systems and compliance strategy as it moves toward global product launch.
Responsibilities include but are not limited to the following:
Lead and maintain the company’s Quality Management System (QMS), ensuring compliance with ISO 13485, QMSR, and other applicable regulatory standards.
Drive Management Review activities, track Quality Objectives, and monitor relevant KPIs.
Prepare and manage internal/external audits and regulatory reporting requirements.
Lead design assurance activities including design controls, verification and validation, and maintenance of the Design History File (DHF).
Develop and validate test methods to assess product performance and ensure compliance.
Oversee and maintain the Document Control System (QT9 eQMS), including administrative tasks.
Lead computer system validation/assurance efforts in line with regulatory requirements.
Manage CAPA, non-conformance investigations, and customer complaint processes.
Direct risk management and usability engineering activities, including user feedback and human factors inputs.
Support the Device Master Record (DMR) and Device History Record (DHR) documentation and control.
Lead Supplier Quality Management: qualification, audits, vendor reviews, and Approved Vendor List maintenance.
Support regulatory strategy, including GAP assessments and updates related to relevant standards.
Collaborate cross-functionally with R&D, Manufacturing, and Regulatory teams to drive continuous improvement.
Contribute to resource planning, team training, and performance management within the quality function.
Lead or support lot release and quality oversight in partnership with contract manufacturers.
Champion a culture of quality throughout the organization and act as a key stakeholder in preparing for market readiness.
Bachelor’s degree in engineering, science, or a related discipline (or equivalent experience).
Minimum of 5 years’ experience in a medical device environment, preferably in a start-up or early-stage company.
Strong knowledge of ISO 13485, GMP, FDA QMSR, and international regulatory requirements.
Hands-on experience with design assurance, quality systems, and supplier quality management.
Familiarity with ISO 14971 and risk management practices.
Experience with validation of test methods, sterilization (EtO or Gamma), packaging, biocompatibility, and labelling is a plus.
Demonstrated ability to lead audits, CAPA processes, and quality planning.
Strong analytical, problem-solving, and root cause analysis skills (DMAIC preferred).
Proficiency with MS Office and electronic QMS tools (e.g., QT9).
Excellent communication, leadership, and cross-functional collaboration skills.
Comfortable in a fast-paced, evolving environment with a hands-on, proactive approach
Immediate interviews available for suitable candidates.
Note: By applying for this position, you may also be considered by Pale Blue Dot Recruitment for other future vacancies.
-Pale Blue Dot Recruitment, The Resource for the MedTech Workforce-
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