Design Quality Assurance Engineer II / III (Contract) and Senior level

 

Location: Galway, Ireland (Hybrid)

Contract Type: Contract

Department: Quality Assurance / Product Development

 

Overview

 

We are seeking three experienced Design Quality Assurance Engineers at either Engineer II or Engineer III and Senior level to join a dynamic medical device team in Galway. The successful candidates will support a combination of New Product Development (NPD) and commercial product lifecycle projects, with assignment based on individual experience, expertise, and business needs.

This role offers the opportunity to work closely with cross-functional teams to ensure product quality, regulatory compliance, and patient safety throughout the product development lifecycle and post-market phases.

 

Job Purpose

The Design Quality Assurance Engineer will provide quality engineering support across product development and/or commercial product activities, ensuring compliance with applicable quality system requirements and international regulatory standards.

The successful candidate will play a key role in supporting design control activities, risk management, product changes, and quality improvements while maintaining a strong focus on patient safety, product performance, and regulatory compliance.

 

Key Responsibilities

Design Quality Assurance

• Provide quality engineering support for new product development and/or commercial product projects.
• Ensure compliance with Design Control requirements throughout the product lifecycle.
• Review and approve design documentation, including design plans, protocols, reports, and technical documentation.
• Support product development activities from concept through commercialization.
• Participate in design reviews and provide quality guidance to project teams.
• Ensure design outputs meet applicable regulatory and quality requirements.

Risk Management

• Facilitate and support risk management activities in accordance with ISO 14971.
• Participate in hazard analyses, risk assessments, and risk-benefit evaluations.
• Ensure risks are appropriately identified, documented, mitigated, and maintained throughout the product lifecycle.

Quality Systems & Compliance

• Ensure compliance with applicable standards and regulations, including FDA, EU MDR, ISO 13485, and internal quality system requirements.
• Support internal and external audits, inspections, and regulatory submissions as required.
• Review and approve engineering changes, change controls, and product modifications.
• Ensure quality deliverables are completed in accordance with project timelines.

Post-Market & Sustaining Activities

• Support investigations relating to complaints, CAPAs, non-conformances, and product quality issues.
• Participate in post-market surveillance activities and trend analysis.
• Assess the impact of design or process changes on product safety, effectiveness, and compliance.
• Support implementation of corrective and preventive actions.

Cross-Functional Collaboration

• Collaborate with R&D, Manufacturing, Regulatory Affairs, Clinical, Supply Chain, and Operations teams.
• Provide quality guidance and support during project planning and execution.
• Drive effective problem-solving and continuous improvement initiatives.

Engineer II Requirements

Education

• Bachelor's Degree (Level 8) in Engineering, Science, Quality, or a related STEM discipline.

Experience

• Approximately 3–4 years' relevant experience within the medical device, pharmaceutical, or highly regulated industry.
• Experience supporting product development and/or sustaining engineering activities.
• Working knowledge of Design Control and Risk Management principles.
• Familiarity with ISO 13485, FDA Quality System Regulations, and EU MDR requirements.
• Experience reviewing technical documentation and supporting quality system activities.

Key Competencies

• Strong analytical and problem-solving skills.
• Effective communication and collaboration skills.
• Ability to work independently while contributing effectively within a team environment.
• Strong attention to detail and quality mindset.

Engineer III Requirements

Education

• Bachelor's Degree (Level 8) in Engineering, Science, Quality, or a related STEM discipline.

Experience

• Approximately 4-5+ years' relevant experience within the medical device, pharmaceutical, or highly regulated industry.
• Significant experience within the medical device, pharmaceutical, or other regulated industry.
• Proven experience providing Design Quality support for New Product Development and/or commercial products.
• Strong knowledge of Design Control, Risk Management, and regulatory requirements.
• Experience leading quality activities within cross-functional project teams.
• Experience supporting audits, inspections, product changes, and complex quality investigations.
• Demonstrated ability to influence stakeholders and drive quality-focused decision making.

 

Key Competencies

 

• Strong technical leadership and decision-making capability.
• Excellent communication and stakeholder management skills.
• Ability to manage multiple priorities and workstreams simultaneously.
• Proven track record of delivering quality solutions in a fast-paced environment.

 

Preferred Experience

 

• Medical device industry experience.
• Experience supporting Class II or Class III medical devices.
• Knowledge of Design Assurance methodologies.
• Experience with product development, verification and validation activities.
• Experience with CAPA, complaint investigations, and post-market surveillance.
• Familiarity with statistical analysis and data-driven decision making.