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:

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

Additional responsibilities include:

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

Essential Skills & Experience

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

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