Quality Assurance Engineer Medical Device jobs

Purpose of the Role

Join a dynamic and high-impact role at the intersection of manufacturing, quality, and product development. As a Quality Assurance Engineer, you will play a critical part in ensuring the delivery of high-quality, compliant products to customers while driving continuous improvement across manufacturing operations.

This is a highly varied role, offering exposure to audits, CAPA, major projects, compliance standards, and new product introductions, ideal for someone who enjoys working across multiple areas and making a visible impact.

What You’ll Do

• Drive Quality & Compliance Excellence
  Identify and resolve manufacturing issues (scrap, non-conformances, complaints) using structured root cause analysis, ensuring robust and sustainable CAPA implementation.
• Own CAPA & Audit Activity
  Lead and support CAPA processes, audit preparation, and audit responses, ensuring inspection readiness at all times.
• Ensure Regulatory & ISO Compliance
  Review processes, documentation, and project work to ensure alignment with ISO and regulatory standards, embedding compliance into all activities.
• Support New Product Introductions (NPI)
  Collaborate with cross-functional teams on new product launches, ensuring quality is built in from development through to commercialisation.
• Contribute to Major Projects
  Play a key role in large-scale projects, including compliance initiatives, process optimisation, and structured project rollouts.
• Drive Continuous Improvement (CIP) Lead or contribute to continuous improvement projects using data-driven methodologies, Lean principles, and Six Sigma tools to reduce variation, improve process capability, and enhance operational performance.
• Use Data to Optimise Processes
  Leverage process monitoring systems to identify critical control points and improve manufacturing capability.
• Support Product & Process Development
  Contribute to quality plans, specifications, risk assessments, and FMEA to ensure robust product design and manufacturing processes.
• Validation & Technical Support
  Participate in validation activities, including protocol/report writing and execution.
• Enhance Customer Outcomes
  Support Field Discrepancy Notification (FDN) investigations, ensuring customer feedback drives meaningful improvements.
• Build Expertise
  Develop strong capability in quality tools and methodologies while contributing to training and knowledge sharing.

What We’re Looking For

Education & Experience

• NFQ Level 7 qualification (or equivalent, full award) in Engineering, Science, or related field
• Minimum 2+ years’ relevant experience in a manufacturing or regulated environment
• Experience in CAPA, audits, project work, and/or new product introduction is highly desirable

Skills & Competencies

Technical & Business Knowledge

• Strong working knowledge of quality systems, processes, and procedures
• Experience operating in a regulated environment (e.g., ISO standards, GMP)
• Ability to review work to ensure compliance with regulatory and ISO requirements
• Understanding of cross-functional business operations

Cognitive Skills

• Solves problems of moderate scope using structured approaches
• Applies judgment within defined procedures
• Understands the impact of technical decisions on quality, compliance, and operations

Influence & Leadership

• Builds strong internal and external relationships
• May lead or contribute to project teams, CIP initiatives, or NPI activities
• Mentors or supports junior engineers
• Able to influence peers and first-line management

Planning & Organisation

• Effectively plans and prioritises work to meet project and production timelines
• Comfortable managing multiple priorities in a varied, fast-paced environment

Decision Making

• Makes decisions within defined frameworks and procedures
• Understands how decisions can impact timelines, resources, and compliance

Supervision

Received:

• Works under general supervision with a high level of autonomy

Provided:

• May guide and support junior staff
• May contribute to performance feedback and development activities

Why This Role Stands Out

• Highly varied position with exposure to manufacturing, audits, compliance, and product development
• Opportunity to apply and further develop Lean Six Sigma and continuous improvement expertise
• Opportunity to work on major projects, CIP initiatives, and new product launches
• Build expertise in CAPA, audits, validation, and ISO/regulatory standards
• Work in a collaborative, quality-driven environment
• Strong opportunities for career progression and development

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