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Senior Quality Assurance Design Transfer Engineer I
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Full-time
bachelor degree
Attractive salary package, Defined contribution pension plan, Health insurance cover, Life assurance, Health & wellbeing events calendar, Career progression opportunities
Posted 26d ago
~40 hrs/week
Responsibilities
Provide quality engineering support for design transfer activities, ensuring products are designed, tested, and manufactured in compliance with internal and agency quality requirements. Lead risk management analysis, manage engineering change notifications, and mentor engineering staff on quality system compliance.
Requirements
Requires a Bachelor's degree in Engineering or a related field and at least eight years of relevant engineering experience. Candidates must demonstrate fluency in English and French, along with expertise in medical device standards such as ISO 13485 and 21 CFR 820.
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.
As a global healthcare company, we understand customer needs and innovate and deliver medical solutions that transform patient care.
Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture, and distribution of proprietary disposable medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy.
Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling in excess of 300 individuals. Merit employs approximately 6,000 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Malvern, Pennsylvania; Rockland, Massachusetts; Aliso Viejo, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Markham, Ontario, Canada; Melbourne, Australia; Tokyo, Japan; Reading, United Kingdom; Johannesburg, South Africa; and Singapore.
Offices: Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, Utah 84095, US · Merit Netherlands-Maastricht, Amerikalaan 42; 6199 AE Maastricht Airport, Maaastricht, n/a, NL · West Jordan Facility, West Jordan, Utah 84088, US · Merit Virginia Facility, 12701 Kingston Ave, Chester, Virginia 23836, US · Parkmore Business Park West, Galway, Ballybrit D02 TD60, IE
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How many Healthcare jobs are open in Galway, Ireland right now?
There are currently 105 open healthcare positions in Galway, Ireland listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Healthcare roles in Galway, Ireland?
Companies currently hiring include Medtronic, CVS Health, Zimmer Biomet, Boston Scientific, ICS Medical Devices, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Healthcare jobs in Galway, Ireland?
Yes — 53 of the 105 open healthcare positions offer remote or hybrid work (0 remote, 53 hybrid).
How do I apply for Healthcare jobs in Galway, Ireland?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.