Find Senior quality assurance Jobs in Galway, G

Senior Quality Assurance Design Transfer Engineer I
Merit Medical Systems Inc. —Galway, County Galway
- Full-time
- Oracle
- Word processing
- Engineering
- Free parking
4d
Senior QA Manager (Quality Systems)
Dexcom —Athenry, County Galway
- €108,715–€140,690 a year
- Full-time
- Bachelor's degree
- No degree
Senior Accountant
Natus Medical Incorporated —Galway, County Galway
- Oracle
- ERP systems
- English
- Free parking
4d
Operations Manager
Clybaun Hotel —Galway, County Galway
- From €45,000 a year
- Full-time
- Hotel
- No degree
- Budgeting
- Free parking
- Employee discount
Quick apply
12d
Collections Advisor
Radius Limited —Galway, County Galway
- Full-time
- Customer service
- Communication skills
- Fuel card
- Employee assistance program
Quick apply
Senior Geotechnical Engineer
Ayesa —Galway, County Galway
- Hybrid work
- Master's degree
- Presentation skills
- Civil Engineering
- Annual leave
- Employee assistance program
Quick apply
13d
Manager Strategic Sourcing
Natus Medical Incorporated —Galway, County Galway
- Full-time
- Continuous improvement
- Free parking
7d
R&D Engineer I
Luminate Medical —Galway, County Galway
- Full-time
- Engineering
- No degree
- Manufacturing
Quick apply
Senior Ecologist
MKO —NUIG, County Galway
- Budgeting
Quick apply
Senior Software Engineer
Liberty IT —Galway, County Galway
- Hybrid work
- Computer Science
- Master's degree
- AWS
- Employee discount
8d
M&E Resident Engineers
AECOM —Galway, County Galway
- Full-time
- Hybrid work
- Supervising experience
- Contracts
- Electrical Engineering
R&D Engineer II
Luminate Medical —Galway, County Galway
- Full-time
- Engineering
- No degree
- Communication skills
Quick apply
Principal Software Engineer - MLOps
Liberty IT —Galway, County Galway
- Hybrid work
- AWS
- IT
- SDLC
- Employee discount
Principal Software Engineer - MLOps
Liberty Information Technology —Galway, County Galway
- Hybrid work
- AWS
- IT
- SDLC
- Employee discount
Senior Quality Engineer
Medtronic —Galway, County Galway
- €64,640–€96,960 a year
- Full-time
- Project management
- Bachelor's degree
- No degree
12d
Senior Regulatory Affairs Specialist
Natus Medical Incorporated —Galway, County Galway
- Microsoft Outlook
- Communication skills
- Free parking
7h
Senior Software Engineer
Liberty Information Technology —Galway, County Galway
- Full-time
- Hybrid work
- Computer Science
- Master's degree
- AWS
- Employee discount
8d

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Senior QA Manager (Quality Systems)
Dexcom —Athenry, County Galway
Must have the ability to change the thinking of, or gain acceptance from, others in sensitive situations, without damage to the relationship.
€108,715–€140,690 a year
QA Specialist - Supplier Quality Management
Chanelle Pharma —Loughrea, County Galway
Bachelor’s degree in a science-related discipline. Ensure all activities are performed in compliance with regulatory standards and company policies, and that…
Quick apply

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Senior Quality Assurance Design Transfer Engineer I

Merit Medical Systems Inc. -
Galway, County Galway

Apply Now

Job details

Full-time
4 days ago

Benefits

Free parking

Qualifications

French
Oracle
Word processing
Engineering
Barista experience
English
Minitab
Project management
Bachelor's degree
Quality control
Computer skills
Quality systems

Full job description

Why Merit?

At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.

SUMMARY OF DUTIES

Provides quality engineering support for products and processes while completing projects in broad areas of assignment supporting design transfer activities. Finalize requirements associated with product development, design controls, and product risk management. Ensures that the products are designed, tested, and manufactured in compliance with all applicable agency/internal quality requirements and optimizing quality systems and documentation.

DUTIES & RESPONSIBILITIES

Participates in design and development activities assuring the design requirements are appropriately transferred into manufacturing. Guides the design team as subject matter expert of Design Control from Design Inputs through Design Outputs, Process Validation, Test Method Validation and Device Master Record creation.
Responsible for coordinating risk analysis/management activities. This may include leading risk management analysis meetings, documenting results, following up to ensure risk mitigation and facilitating improvements.
Reviews, approves, and generates Engineering Change Notifications (ECNs) to update or generate verification, validation, monitoring and inspection methods, procedures, and test protocols; specific to assigned product line(s) and processes and production control(s).
Conducts complete and conceptually related studies to approach technical problems, where the problems are difficult to define, require unconventional or novel approaches, and require sophisticated research techniques.
Performs technical work where available guides and precedents contain critical gaps, are only partially related to the problem, or may be largely lacking due to the novel character of the project.
Contributes techniques which are of material significance to solve specific problems and drive continuous improvement.
Keeps abreast of new scientific methods, standards, regulations, and developments affecting the organization for the purpose of recommending changes to processes, systems or designs warranted by such developments.
May plan, organize and mentor engineers or technicians on various engineering projects and quality system compliance issues.
Mentors and evaluates competency of Quality Auditors, Design Assurance/Quality Engineers, and technicians, by providing training or other actions required to satisfy quality objectives.
Reviews nonconformance records (internal/external) to determine disposition, root cause, and need for corrective and preventive actions.
Ensures containment (identification, segregation, and reconciliation) of nonconforming product has been performed, to prevent unintended use.
Identifies and implements any changes necessary to ensure and maintain the continued suitability and effectiveness of the quality management system through the use of quality policy, quality objectives, audit results, analysis of data, risk management, etc.
Evaluates the work environment in which product is manufactured, and ensures it is adequately controlled and monitored, with sufficient personnel and safety production controls.
May support Internal Audit and supplier audit activities, performing audits, writing audit reports, and following up on effectiveness of corrective/preventative actions.
Performs a variety of other tasks and related work, as required.

SUMMARY OF MINIMUM QUALIFICATIONS

Education and/or experience equivalent to a Bachelor's Degree in Engineering or related field.
Language: English (Fluency) and French (Fluency)
A minimum of eight (8) years of engineering experience.
Demonstrated working knowledge of 21 CFR 820 (Quality Systems Medical Devices), ISO 13485, ISO14791, and other medical device related standards.
Working knowledge of statistical methodologies, quality control and manufacturing tools such as problem solving, root cause investigation, applied statistics, lean manufacturing, Six Sigma, etc., and project management experience.
Expertise in design and development of Test Method Validations (TMV).
Expertise in creating and conducting Master Validation Plans (MVP).
Experience in conducting Validations (IQ, OQ, PQ).
Knowledge of applicable regulatory agency regulations.
Demonstrated computer skills, preferably spreadsheets, word processing, database, and other applicable software programs.

PREFERRED QUALIFICATIONS

Medical device experience or equivalent experience in a regulated industry.
Experience with Minitab or JMP, Oracle.
Passed ASQ Certified Quality Engineering exam.

#IJA

Key Benefits

Attractive Salary package
Defined Contribution Pension Plan
Health Insurance Cover
Life assurance
Health & Wellbeing Events Calendar
Excellent career progression opportunities
Recognition scheme
Free Parking
Educational assistance
Internal training courses
Quality Subsidised Canteens & Barista Service
Active Sports and Social Club

We are Global

Merit Medical Galway commenced with 22 employees in 1993. Since then Merit has enjoyed year on year revenue growth and developed its workforce to over 900 employees. Headquartered in Salt Lake City, Utah, Merit maintains a diverse, multi-campus manufacturing footprint in Europe, North America, South America, Asia and Australia with a global distribution.

Medtech Company of the Year Winner

Merit Medical Galway are proud winners of the Medtech Company of the Year Award, a prestigious award recognizing those who are exceling in the MedTech industry.

People Development

At Merit Medical Galway almost 60% of all roles are filled by internal employees! We focus on encouraging, believing in and providing a platform for you to progress your career!

Culture

A supportive and collaborative environment make Merit Medical a friendly, enjoyable place to work. We are proud of our energetic and dynamic culture. Diversity & Inclusion is evident here with an 50/50 ratio of male and female employees as well as 30 nationalities onsite! We value every employee as an individual.

To see more on our culture, go to www.merit.com/careers .

Apply Now

Refine Your Search

senior quality assurance jobs in galway, g

Senior Quality Assurance Design Transfer Engineer I

Senior QA Manager (Quality Systems)

Senior Accountant

Operations Manager

Collections Advisor

Senior Geotechnical Engineer

Manager Strategic Sourcing

R&D Engineer I

Senior Ecologist

Senior Software Engineer

M&E Resident Engineers

R&D Engineer II

Principal Software Engineer - MLOps

Principal Software Engineer - MLOps

Senior Quality Engineer

Senior Regulatory Affairs Specialist

Senior Software Engineer

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