Find mechanical engineer Jobs in galway, g

Senior Quality System Engineer
Haemonetics Corp. —Galway, County Galway
- Full-time
- Engineering
- No degree
- Mentoring
Service Co-Ordinator
Henley Forklift Group —Galway, County Galway
- Microsoft Word
- Microsoft Excel
- Customer service
23h
Thermal Engineer
MBRYONICS —Galway, County Galway
- Full-time
- Doctoral degree
- Engineering
- Master's degree
Senior Manufacturing Engineer
Freudenberg Medical Ireland Ltd —Spiddal, County Galway
- Engineering
- Project management
- Continuous improvement
Manufacturing Maintenance Technician
Celestica —Galway, County Galway
- No degree
- Communication skills
Senior Systems Engineer
Medtronic —Galway, County Galway
- €64,640–€96,960 a year
- Full-time
- Engineering
- System design
- Bachelor's degree
5d
Engineering Supervisor (Packaging)
Dexcom —Athenry, County Galway
- 12 hour shift
- No degree
- Manufacturing
Senior Opto-Mechanical Design Engineer
MBRYONICS —Galway, County Galway
- Full-time
- CAD
- Engineering
- Research
Optical Assembly, Integration & Test (AIT) Engineer
MBRYONICS —Galway, County Galway
- Full-time
- Engineering
- Assembly
- Bachelor's degree
Engineering Supervisor (Front End Night Shift)
Dexcom —Athenry, County Galway
- 12 hour shift
- Supervising experience
- No degree
- Manufacturing
Customer Program Coordinator (MRO)
CEC —Galway, County Galway
- Full-time
- Inventory control
- Engineering
- ERP systems
Quick apply
Engineering Technician 2 (Weekend Day Shift)
Dexcom —Athenry, County Galway
- 12 hour shift
- No degree
- Manufacturing
6d
Lead Systems Engineer
MBRYONICS —Galway, County Galway
- Full-time
- System design
- No degree
- Scripting
Engineering Technician Supervisor (Weekend Day Shift)
Dexcom —Athenry, County Galway
- 12 hour shift
- Supervising experience
- No degree
- Manufacturing
Controls Technician 2 (Front End Day Shift)
Dexcom —Athenry, County Galway
- Full-time
- No degree
- Manufacturing
6d
Principal Mixed-Signal Hardware Engineer
Medtronic —Galway, County Galway
- €81,120–€121,680 a year
- Full-time
- Doctoral degree
- Master's degree
- Bachelor's degree
Senior Design Assurance Engineer
Luminate Medical —Galway, County Galway
- Full-time
- Microsoft Excel
- No degree
- Communication skills
Quick apply
Senior Systems Engineer
MBRYONICS —Galway, County Galway
- Full-time
- System design
- Scripting
- Agile
Site Engineer - Galway
EPS Group —Galway, County Galway
- Full-time
- AutoCAD
- Engineering
- Microsoft Office
Quick apply
Project Design Engineer - REF: 2518
Fingleton White —Galway, County Galway
- Full-time
- Hybrid work
- Engineering
- English
- Microsoft Office
- Annual leave
- Employee assistance program
Quick apply

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Senior Quality System Engineer

Haemonetics Corp. -
Galway, County Galway

Apply Now

Job details

Full-time

Qualifications

Engineering
Mentoring
Quality systems
ISO 13485

Full job description

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice.

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.

EEO Policy Statement

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Refine Your Search

mechanical engineer jobs in galway, g

Senior Quality System Engineer

Service Co-Ordinator

Thermal Engineer

Senior Manufacturing Engineer

Manufacturing Maintenance Technician

Senior Systems Engineer

Engineering Supervisor (Packaging)

Senior Opto-Mechanical Design Engineer

Optical Assembly, Integration & Test (AIT) Engineer

Engineering Supervisor (Front End Night Shift)

Customer Program Coordinator (MRO)

Engineering Technician 2 (Weekend Day Shift)

Lead Systems Engineer

Engineering Technician Supervisor (Weekend Day Shift)

Controls Technician 2 (Front End Day Shift)

Principal Mixed-Signal Hardware Engineer

Senior Design Assurance Engineer

Senior Systems Engineer

Site Engineer - Galway

Project Design Engineer - REF: 2518

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