Senior Design Assurance Engineer

7 days ago

Galway, Ireland Wallace Myers International Full time

Position: Senior Design Assurance Engineer


Role Overview
The Senior Design Assurance Engineer will act as the QA technical and compliance expert within a cross-functional team, supporting the design and development of sterile and non-sterile medical devices, as well as subsequent modifications, in line with regulatory requirements (ISO 13485, 21 CFR 820/QMSR, and other applicable international standards).

Key Responsibilities


Lead quality-related activities including:


Risk assessments
Device testing and associated validations
Internal and external audits, serving as SME for design processes
Generation and/or approval of technical documents on behalf of the Quality function
Management of Design History Files (DHF)
Continuous improvement of the Quality Management System (QMS)


Additional responsibilities include:


Ensure compliance of product development and risk management activities with governing regulatory requirements.
Collaborate with product development teams to translate user needs into design requirements, identify critical features/components, and generate risk management and quality documentation.
Execute design verification, validation, and test method validation activities.
Partner with R&D and Manufacturing Engineering to translate design requirements into manufacturing specifications, develop test methods, and implement process monitoring activities.
Lead resolution of project issues by applying structured problem-solving methodologies and coordinating with internal and external stakeholders.
Monitor regulatory compliance, identify process improvements, and implement system enhancements.
Apply statistical techniques and analysis to support decision-making across product development and manufacturing.
Represent the organisation professionally to external agencies, vendors, and regulators.
Lead and/or support compliance and improvement initiatives within the QMS (e.g., CAPA, audits, training).
Plan, execute, and report on quality system audits; act as audit escort or provide backroom support during inspections.
Track project and departmental progress, report risks, and support teams with contingency planning.
Review and approve operational, test, and validation data for equipment, materials, components, and products to ensure compliance with specifications.
Provide technical quality guidance, mentoring junior engineers and supporting inspection staff.
Act as system administrator for statistical tools (e.g., Minitab).
Ensure compliance to the Quality Manual and QMS requirements.

Essential Skills & Experience


Bachelor's degree in Engineering, Science, or related technical discipline.
Minimum of 6 years' experience in Quality Assurance, Quality Systems, or Regulatory Affairs within the medical device industry.
At least 4 years in QA activities related to product design and development.
Project management and leadership experience preferred.
In-depth knowledge of FDA 21 CFR Part 820 (QMSR), ISO 13485:2016, EU MDR, Canadian Medical Device Regulations, and other international standards.
Proven track record in preparing for and participating in notified body and FDA inspections.
Strong problem-solving, decision-making, and analytical skills.
Results-driven with the ability to manage multiple priorities in a fast-paced environment.
Excellent interpersonal skills with the ability to influence and collaborate effectively across teams.
Strong written and verbal communication skills, with fluency in English.
Proficiency in MS Office and statistical software (e.g., Minitab).
High motivation, initiative, and ability to work independently as well as part of a team.
Strong business acumen and ability to balance quality and organisational objectives.


This is a senior-level opportunity to lead quality and compliance activities in medical device design, directly influencing the safety, reliability, and market success of life-changing technologies.

At Wallace Myers International Recruitment Agency we specialise in sourcing professionals for key industries and services.

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