About the Role / Job Description
Senior Quality Systems Engineer – Galway, supporting a growing medical device business as it transitions from a start‑up environment into a scaled, high‑volume operation.
This hands‑on role involves taking ownership of the site Quality Management System, ensuring it remains compliant, effective, and fit for purpose. In parallel, you will play a key role in the integration of a global QMS following acquisition, helping to align ways of working while maintaining the agility and strengths of the existing site. You’ll work closely with both local teams and global stakeholders, with real opportunity to influence how quality systems evolve on site.
Essential Duties
Ownership of the site QMS, ensuring ongoing compliance with ISO 13485, FDA 21 CFR Part 820, and EU MDR
Lead and support core QMS processes including:
CAPA
Change Control
Nonconformance Management
Document Control
Internal Audits
Management Review
Maintain a state of audit readiness, supporting notified body and regulatory inspections
Act as a go‑to QMS subject matter expert on site
Support and lead elements of the integration of the acquiring company’s global QMS
Carry out practical gap assessments and help define how best to align systems and processes
Develop and execute clear, phased integration plans, with a focus on maintaining compliance and minimising disruption to operations
Work with global teams to harmonise procedures and systems, while ensuring they are workable at site level
Apply risk‑based thinking to QMS updates and integration activities
Partner with Operations, R&D, Regulatory, and Supply Chain to ensure QMS processes are understood and effectively applied
Provide day‑to‑day support and development to direct report(s)
Contribute to building a strong quality culture across the site
Identify opportunities to simplify and improve QMS processes, particularly as the site scales
Qualifications
Education
Degree in Engineering, Science, or a related discipline
Experience
5+ years’ experience in a Quality role within the medical device industry
Strong working knowledge of ISO 13485, FDA QSR (21 CFR Part 820), EU MDR
Experience maintaining and improving a practical, working QMS in a manufacturing environment
Exposure to QMS integration, harmonisation, or significant change activities would be a strong advantage
Previous experience mentoring or supporting engineers is desirable
Skills / Strengths
Practical, hands‑on approach to quality systems
Strong understanding of how QMS works in a real manufacturing environment
Ability to balance compliance requirements with operational realities
Good communicator, comfortable working across functions and levels
Organised, with a focus on delivering clear, workable solutions
Problem Solving
Highly thorough and dependable
Independent in task execution. Meticulous, focus and attentive to details and accuracy in all aspects of the job
Positive attitude, able to influence and lead different groups of employees, motivate and guide people toward organisational success
Analytical minded, resourceful, data driven, using quality tools and methodology to deliver results
Training/Certifications
International standards: ISO13485, ISO19011, ISO14971
Regulatory laws: 21CFR820, 21CFR11, 21CFR803, GDPMD, Malaysia Medical Device Act 2012, Canadian MDR, EU Directive 2007/47/EC, MHLW Ord. 169, Medical Device Single Audit Program (MDSAP), EU Medical Device Regulation (EU MDR 2017/745).
Physical Demand
Sit; use hands to finger, handle, or feel objects, tools, or controls.
Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.
Lifting/moving up to 10 pounds.
Exposure to moving mechanical parts, vibration and/or moderate noise levels.
Exposure to hazardous chemicals or other materials.
EEO Policy Statement
#J-18808-Ljbffr