Find senior quality system engineer Jobs in galway, g

Senior Quality System Engineer
Haemonetics Corp. —Galway, County Galway
- Full-time
- Engineering
- No degree
- Mentoring
Senior Supplier Quality Engineer
Natus Medical Incorporated —Galway, County Galway
- Engineering
- Analysis skills
- Bachelor's degree
Senior Quality Engineer
ICS Medical Devices —Galway, County Galway
- Full-time
- Engineering
- Employee assistance program
- Sick pay
Quick apply
Senior Design Quality Engineer
Vita Data Sciences —Galway, County Galway
- Full-time
- In-person
Senior Software Engineer - Application Spec (Patient Case Systems)
Medtronic —Galway, County Galway
- €65,600–€98,400 a year
- Full-time
- Computer Science
- Java
- C++
Senior Engineer
BAM Building —Galway, County Galway
- Organisational skills
- Leadership
- Communication skills
- Annual leave
Senior Software Test Engineer - Carelink
Medtronic —Galway, County Galway
- €64,640–€96,960 a year
- Full-time
- Azure
- Master's degree
- AWS
Senior Systems Engineer
Medtronic —Galway, County Galway
- €64,640–€96,960 a year
- Full-time
- Engineering
- System design
- Bachelor's degree
6d
Senior Software Engineer - Verification Testing
Medtronic —Galway, County Galway
- €65,600–€98,400 a year
- Full-time
- Computer Science
- Java
- C++
Senior Software Engineer-Typescript
Liberty Information Technology —Galway, County Galway
- Full-time
- Hybrid work
- Computer Science
- AWS
- Software development
- Employee discount
Principal Software Engineer - Framework - Patient Care Systems
Medtronic —Galway, County Galway
- €83,520–€125,280 a year
- Full-time
- Computer Science
- Java
- C++
Senior Software Engineer - Catalyst Team (Patient Care Systems)
Medtronic —Galway, County Galway
- €65,600–€98,400 a year
- Full-time
- Azure
- Computer Science
- DevOps
Senior Software Engineer - PathMakers (Patient Care Systems)
Medtronic —Galway, County Galway
- €65,600–€98,400 a year
- Full-time
- Azure
- Computer Science
- Windows
Senior Maintenance Work Management Engineer – Global CAMS Deployment (12 Month Contract)
Medtronic —Galway, County Galway
- €64,640–€96,960 a year
- Full-time
- Management
- Engineering
- Maintenance
6d
Senior Principal System Architect - Digital Ecosystem Coronary and Renal Denervation CRDN
Medtronic —Galway, County Galway
- €94,720–€142,080 a year
- Full-time
- Doctoral degree
- Master's degree
- AWS
Senior Process Engineer
Dexcom —Athenry, County Galway
- Full-time
- Doctoral degree
- Master's degree
- Bachelor's degree
Senior Software Engineer - Carelink
Medtronic —Galway, County Galway
- €65,600–€98,400 a year
- Full-time
- Azure
- Master's degree
- AWS
Medical Device Engineer Level 1
Galway Biomedical Ltd —Ballybrit, County Galway
- €50,000–€55,000 a year
- Full-time
- CAD
- Engineering
- Analysis skills
- Employee assistance program
Quick apply
Senior Engineer I
Merit Medical Systems Inc. —Galway, County Galway
- Full-time
- Doctoral degree
- Word processing
- Engineering
- Free parking
Senior Systems Engineer
MBRYONICS —Galway, County Galway
- Full-time
- System design
- Scripting
- Agile

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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

senior quality system engineer jobs in galway, g

Senior Quality System Engineer

Senior Supplier Quality Engineer

Senior Quality Engineer

Senior Design Quality Engineer

Senior Software Engineer - Application Spec (Patient Case Systems)

Senior Engineer

Senior Software Test Engineer - Carelink

Senior Systems Engineer

Senior Software Engineer - Verification Testing

Senior Software Engineer-Typescript

Principal Software Engineer - Framework - Patient Care Systems

Senior Software Engineer - Catalyst Team (Patient Care Systems)

Senior Software Engineer - PathMakers (Patient Care Systems)

Senior Maintenance Work Management Engineer – Global CAMS Deployment (12 Month Contract)

Senior Principal System Architect - Digital Ecosystem Coronary and Renal Denervation CRDN

Senior Process Engineer

Senior Software Engineer - Carelink

Medical Device Engineer Level 1

Senior Engineer I

Senior Systems Engineer

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