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Design Quality Assurance Engineer - Job Opportunity at Nordson Medical

Galway, Ireland
Full-time
Mid-level
Posted: July 1, 2025
On-site
EUR 55,000 - EUR 70,000 annually. This estimate reflects Ireland's competitive medical device sector, Nordson's position as a global leader, and the specialized nature of medical device quality engineering. The Galway location, being a major medical device hub, typically offers salaries at the higher end of the European range for this experience level.

Benefits

Opportunity to work in a dynamic and collaborative environment where ideas and contributions are valued and respected
Professional development through leading quality roles on client programs and implementing new methodologies
International exposure through interactions with global customers and suppliers
Career advancement opportunities within a global leader in the medical device industry
Inclusive and diverse workplace culture with commitment to equity and belonging

Key Responsibilities

Lead quality engineering initiatives on projects, establishing comprehensive quality documentation that ensures regulatory compliance and market readiness
Develop and execute strategic planning for pilot production and scale-up operations in New Product Introduction programs, directly impacting time-to-market success
Ensure cross-functional project teams maintain adherence to Nordson Medical Quality Systems and regulatory standards throughout the entire product development lifecycle
Conduct comprehensive design risk assessments to validate product functionality and safety, protecting both patient outcomes and company liability
Manage critical quality processes including CAPA implementation, change control, vendor audits, and product release decisions that directly impact revenue and compliance
Build and maintain strategic relationships with customers and suppliers through professional communication and proactive information exchange
Provide technical leadership in resolving complex quality issues, preventing costly delays and maintaining customer satisfaction
Drive continuous improvement initiatives within the Quality Management System, enhancing operational efficiency and competitive advantage
Lead quality strategy development for client programs, bringing innovative concepts to market through robust product and process documentation
Coordinate multi-stakeholder activities with external suppliers and consultants to ensure on-time delivery and project success

Requirements

Education

Minimum Bachelor's degree in Engineering or related field

Experience

3 years of medical device design and development/quality assurance experience is required

Required Skills

Managing customer relationships and responses in a timely manner Ability to interact with client companies in a professional manner Demonstrated ability to lead product verification & validation activities Experience working with operations to develop strong manufacturing process instructions Familiarity with FDA QSRs, medical device regulations and ISO 13485 Knowledge of probability and statistics Organised and able to self-manage project tasks Customer focus with excellent communication skills, written and oral Experience using an electronic quality management system (eQMS) Flexibility, persistence, resourcefulness, a drive to succeed, and an entrepreneurial spirit

Certifications

Lean or Six Sigma certification/experience Auditor experience preferred (i.e. Supplier, Customer, Third Party, Quality Management System (QMS))
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Sauge AI Market Intelligence

Industry Trends

The medical device industry is experiencing unprecedented regulatory scrutiny with FDA and EU MDR requirements becoming increasingly stringent, creating high demand for quality professionals who can navigate complex compliance landscapes while maintaining innovation velocity. Digital transformation in medical device manufacturing is driving the need for quality engineers proficient in electronic quality management systems and data-driven decision making, as companies seek to leverage Industry 4.0 technologies for enhanced quality control. The shift toward personalized medicine and minimally invasive devices is creating new quality challenges, requiring professionals who can adapt traditional quality frameworks to emerging technologies and novel therapeutic approaches. Post-pandemic supply chain vulnerabilities have elevated the strategic importance of supplier qualification and vendor audit expertise, making these skills critical for ensuring continuity and quality in global medical device operations.

Role Significance

Typically leads cross-functional project teams of 5-8 members including R&D engineers, manufacturing specialists, and regulatory affairs professionals, while reporting to a Quality Director or VP of Quality in a matrix organization structure.
This is a mid-to-senior level individual contributor role with significant leadership responsibilities. The position requires someone who can operate independently while guiding others, indicating a role that sits between senior specialist and management track positions.

Key Projects

New product introduction programs for next-generation medical devices, managing quality aspects from concept through market launch Implementation of advanced quality management systems and digital quality platforms to enhance operational efficiency Strategic supplier qualification and audit programs to ensure global supply chain quality and compliance Cross-functional process improvement initiatives using Lean Six Sigma methodologies to reduce defects and enhance customer satisfaction

Success Factors

Deep technical expertise in medical device regulations combined with practical application skills enables navigation of complex compliance requirements while maintaining innovation momentum. Strong stakeholder management abilities are essential for coordinating between internal teams, external suppliers, and regulatory bodies to ensure seamless project execution. Systems thinking and process optimization mindset allows identification of improvement opportunities that deliver measurable business impact while maintaining quality standards. Adaptability and continuous learning orientation enables success in the rapidly evolving medical device landscape where new technologies and regulations constantly emerge.

Market Demand

High demand. The medical device quality engineering field is experiencing strong growth due to aging populations, increased regulatory requirements, and rapid technological advancement in healthcare. Ireland's position as the "Medical Device Capital of Europe" creates particularly strong local demand.

Important Skills

Critical Skills

FDA QSR and ISO 13485 expertise forms the regulatory foundation essential for any medical device quality role, as non-compliance can result in product recalls, FDA warning letters, and significant financial penalties that threaten business viability. Risk management and design control capabilities are fundamental to patient safety and product success, as inadequate risk assessment can lead to device failures that harm patients and expose companies to liability. Cross-functional leadership and communication skills enable effective collaboration across diverse technical teams, ensuring quality requirements are understood and implemented throughout the product development process. Statistical analysis and data interpretation abilities support evidence-based decision making in quality management, enabling proactive identification of trends and implementation of preventive measures.

Beneficial Skills

Lean Six Sigma methodology provides structured problem-solving tools that enhance operational efficiency and reduce costs while maintaining quality standards, making practitioners valuable for continuous improvement initiatives. Electronic quality management system experience positions professionals for digital transformation initiatives that are reshaping quality operations across the medical device industry. Supplier audit and qualification expertise becomes increasingly valuable as companies seek to optimize global supply chains while maintaining stringent quality requirements. Customer relationship management skills differentiate quality professionals by enabling them to translate technical quality requirements into business value propositions that strengthen customer partnerships.

Unique Aspects

The role combines strategic quality leadership with hands-on technical execution, offering both depth and breadth of experience that accelerates career development in the medical device industry.
Direct involvement in new product introduction programs provides exposure to cutting-edge medical technologies and innovative therapeutic approaches, enhancing technical expertise and market knowledge.
The position offers international exposure through global customer and supplier interactions, building valuable cross-cultural competencies and expanding professional networks.
Integration with Nordson's broader technology portfolio provides unique insights into advanced manufacturing processes and precision engineering that extend beyond traditional medical device quality roles.

Career Growth

Career progression typically occurs within 2-4 years for high performers, with pathway dependent on individual preferences between technical depth, people management, or strategic leadership tracks.

Potential Next Roles

Senior Quality Engineer with expanded technical leadership responsibilities Quality Manager overseeing multiple product lines or regional operations Regulatory Affairs Manager focusing on global compliance strategy Program Manager for new product development initiatives Quality Director with P&L responsibility for quality operations

Company Overview

Nordson Medical

Nordson Medical operates as a specialized division of Nordson Corporation, focusing exclusively on precision medical device components and systems. The company serves as a critical supplier to major medical device manufacturers, providing components for drug delivery systems, minimally invasive surgical devices, and diagnostic equipment.

Nordson Medical holds a strong position in the medical device component manufacturing sector, leveraging parent company Nordson's 60+ years of precision dispensing and processing technology expertise. The company is recognized for innovation in fluid management and precision assembly solutions for medical applications.
The Galway location serves as Nordson Medical's European hub, capitalizing on Ireland's position as home to 9 of the top 10 global medical device companies. This strategic location provides access to the European market while benefiting from Ireland's favorable business environment and skilled workforce.
Nordson Medical emphasizes a collaborative, innovation-driven culture with strong focus on diversity and inclusion. The company culture balances entrepreneurial spirit with systematic quality management, encouraging both creative problem-solving and rigorous process adherence.
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