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Job Details

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 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 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 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, 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 aspect 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: 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.

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