Senior Quality Engineer – Design Assurance

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  • Limerick
  • Permanent
  • Full-time
  • 1 month ago
  • Apply easily
Skillsource is partnering with a leading global organisation in the medical technology sector to recruit a Senior Quality Engineer – Design Assurance. This role supports both new product development and sustaining engineering, ensuring products are designed, developed, changed, and maintained in full alignment with global regulatory expectations and internal quality standards.The successful candidate will act as the Quality representative on project core teams, providing leadership on design control, risk management, and compliance throughout the product lifecycle. The position requires strong communication, analytical capability, and confidence in guiding cross‑functional teams through regulatory and quality expectations.Role PurposeAs Senior Quality Engineer – Design Assurance, you will be responsible for applying Quality Engineering principles across multiple projects, ensuring all design activities meet regulatory, corporate, and quality system requirements. You will support product development from concept through to launch, and contribute to ongoing product improvement initiatives.This role is central to driving a strong quality culture and ensuring that risk management, design documentation, verification and validation (V&V), and compliance deliverables are robust, traceable, and audit‑ready.Key ResponsibilitiesDesign Assurance Leadership
  • Act as the Design Assurance Quality Engineer on project core teams for both new product development and design change projects.
  • Develop close working relationships with R&D, Compliance, Manufacturing, Regulatory and extended Quality teams.
  • Ensure design control processes are followed and documented appropriately throughout each project phase.
Design History File (DHF) & Documentation
  • Contribute to the creation and maintenance of Design History File (DHF) documentation, ensuring completeness and regulatory readiness.
  • Review and approve V&V plans, test protocols, reports, and supporting documentation.
Risk Management
  • Lead risk management activities in accordance with ISO 14971.
  • Support cross‑functional teams in applying robust risk assessment and mitigation practices.
  • Ensure risk documentation is maintained, traceable, and consistent with product requirements and changes.
Compliance & Standards
  • Support compliance activities relating to relevant medical device standards (e.g., electrical, software, usability).
  • Partner with the Compliance function to drive adherence to applicable regulatory requirements such as IEC 60601 and IEC 62304.
  • Ensure design changes meet global and corporate standards.
Verification, Validation & Statistical Review
  • Work with R&D to develop comprehensive testing strategies and V&V plans.
  • Review, challenge, and approve test methodologies, statistical approaches, sample sizes, acceptance criteria, and rationales.
  • Assess and authorise deviations associated with test execution.
Quality Investigations & Issue Management
  • Lead or support failure investigations, root‑cause analysis, and structured problem‑solving initiatives.
  • Manage and track software issues in alignment with IEC 62304, ensuring appropriate risk assessment and documented dispositions.
Quality Culture & Cross‑Functional Influence
  • Advocate for strong quality behaviours within project teams.
  • Influence decision‑making and escalate blocking issues when product quality or compliance is at risk.
Quality System Activities
  • Contribute to broader QMS activities, including:
  • CAPA
  • Field assessments
  • Operations engineering evaluations
  • General QMS compliance tasks
Candidate ProfileEssential Qualifications & Experience
  • Degree in Engineering or related discipline, or minimum 5 years relevant quality engineering experience.
  • Strong knowledge of ISO 13485, QSR, ISO 14971, and statistical techniques.
  • Demonstrated expertise in design assurance, including design controls, compliance, and risk management.
  • Experience working within regulated medical‑device environments.
  • Strong organisational, analytical, written, and verbal communication skills.
  • Ability to influence cross‑functional teams and drive resolution of quality‑related concerns.
Desirable Experience
  • Working knowledge of MDR.
  • Experience with IEC 62304 (medical software lifecycle) and IEC 62366 (usability engineering).
  • Familiarity with documentation systems, change control tools, and quality‑system software.
Working ModelThis role requires strong on‑site collaboration due to the nature of product development and cross‑functional interaction. A minimum presence of four days per week on‑site is expected to support effective teamwork, communication, and problem‑solving.Contract Details
  • Type: Full‑time
  • Level: Mid‑Senior
  • Travel: Occasional
  • Visa Sponsorship: Not available
  • Security Clearance: Not required
Why Apply?This position offers an opportunity to be directly involved in shaping high‑impact medical technologies. You will influence product quality and safety from concept to launch, work with talented multidisciplinary teams, and contribute to a culture that values innovation, patient safety, and continuous improvement.

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