About the Role / Job Description
We are looking for a Senior Quality Systems Engineer to join our team in Galway, supporting a growing medical device business as it transitions from a start-up environment into a scaled, high-volume operation.
This is a hands-on role where you will take 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 *****, FDA 21 CFR Part 820, and EU MDR
Lead and support core QMS processes including CAPA, Change Control, Nonconformance Management, Document Control, Internal Audits, and 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 harmonize 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 *****, FDA QSR (21 CFR Part 820), EU MDR
Experience maintaining and improving a practical, working QMS in a manufacturing environment
Exposure to QMS integration, harmonization, 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
Organized, 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 employee, motivate and guide people towards organizational success
Analytical minded, resourceful, statistical based decision, data driven direction, use quality tools and methodology in delivering results
Training / Certifications
International standards: ISO*****, ISO*****, ISO*****
Regulatory laws: 21CFR820, 21CFR11, 21CFR803, GDPMD, Malaysia Medical Device Act ****, Canadian MDR, EU Directive *******/EC, MHLW Ord. 169, Medical Device Single Audit Program (MDSAP), EU Medical Device Regulation (EU MDR ********)
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.
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