Quality Systems Lead: MedTech Quality & QMS Excellence

BD; Limerick; On-site; EUR 76,000 - 116,000; Full time

Job summary

Waters Ireland Design Center seeks a Quality Systems Lead to drive QMS compliance for medical device and IVD development. You will partner with US-based teams and own the site QMS, aligning with global standards and regulatory requirements.

You will collaborate with Engineering, Regulatory Affairs, and R&D to enable safe, effective healthcare solutions while delivering continuous improvement and training across the site.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or another technical discipline.
• At least 8 years of experience in a regulated industry such as medical devices, diagnostics, pharmaceuticals, or biologics.
• Strong knowledge of FDA QMSR/21 CFR 820, ISO 13485, ISO 14971, IVDR, and product development quality requirements.
• Proven experience supporting Design Controls, CAPA, change control, audit management, risk management, and regulatory inspections.
• Ability to influence, build effective working relationships, and make sound decisions in complex environments.
• Experience using electronic quality management systems such as TrackWise, Veeva, Agile PLM, SAP, or Windchill, combined with strong communication, problem-solve, and project management skills.

Responsibilities

• Lead the implementation, maintenance, and continuous improvement of the site's Quality Management System.
• Ensure compliance with FDA QMSR/21 CFR 820, ISO 13485, ISO 14971, IVDR, and other applicable regulatory requirements.
• Act as the primary quality partner for Engineering, Regulatory Affairs, R&D, and facility management teams.
• Support Design Verification, Design Validation, and Risk Management activities throughout the product development lifecycle.
• Manage key quality processes, including document control, training, change control, CAPA, audit management, and compliance assessments.
• Coordinate and support external audits, inspections, and regulatory reviews.
• Monitor QMS effectiveness through quality metrics, management reviews, and performance assessments.
• Deliver quality training and promote a culture of compliance, continuous improvement, and accountability.

Skills

Influence

Relationship-building

Decision making

Project management

Education

Bachelor's degree in Engineering/Life Sciences

Tools

TrackWise

Veeva

Agile PLM

SAP

Windchill

Job description

Waters Ireland Design Center seeks a Quality Systems Lead to drive QMS compliance for medical device and IVD development. You will partner with US-based teams and own the site QMS, aligning with global standards and regulatory requirements.

You will collaborate with Engineering, Regulatory Affairs, and R&D to enable safe, effective healthcare solutions while delivering continuous improvement and training across the site.