Quality Engineer

Overview

The primary purpose of this role is to provide Quality Engineering support across manufacturing, quality control, facilities, IT, regulatory affairs, analytical laboratories, research and development, new product introduction (NPI), sustaining engineering, and post-market activities.

The role includes responsibility for quality systems, validation activities, risk management, non-conformance management, corrective and preventive actions (CAPA), audit support, data analysis, microbiological and sterilisation reviews, and continuous improvement initiatives.

Key Responsibilities

• Review and approve validation documentation, change requests, Design and Process FMEAs, software validation documentation, microbiological and sterilisation assessments, and critical system work orders.
• Provide Quality Engineering support to Research & Development, New Product Introduction (NPI), and Sustaining Engineering teams through all stages of product development and transfer to production.
• Review and support design assurance activities, including:
  • Design Inputs
  • Design Verification
  • Design Validation
  • Design Transfer
  • Product Transfer
  • Design and Process FMEAs
  • Process Validation
• Partner with Production and Quality Control teams to support:
  • Incoming Quality Control
  • In-Process Quality Control
  • Final Product Release Activities
• Lead and support Corrective and Preventive Action (CAPA) activities and Non-Conforming Product processes.
• Conduct and support field action assessments and related activities.
• Support internal and external audit programmes and represent Quality Engineering during audits.
• Analyse quality metrics and trends to identify systemic risks and drive improvement initiatives.
• Initiate, manage, and deliver continuous improvement projects.
• Ensure quality issues are prioritised, investigated, and resolved in a timely manner.
• Provide technical guidance and informal mentoring to junior quality engineering personnel.
• Collaborate cross-functionally to ensure compliance with quality management system and regulatory requirements.
• Make risk-based quality decisions within established quality and regulatory frameworks.

Required Qualifications & Experience

• Third-level qualification in Science, Engineering, or a related technical discipline.
• Minimum of 3 years' experience in a Quality Engineering role or related technical field.
• Strong knowledge of medical device regulations and standards, including ISO, EU MDR, and FDA requirements.
• Demonstrated experience across validation disciplines, including:
  • Design Validation
  • Process Validation
  • Software Validation
• Good working knowledge of statistical analysis and quality tools.
• Experience supporting quality systems in a regulated manufacturing environment.
• Proficiency in Microsoft Office applications.

Desirable Qualifications & Experience

• Qualification in Quality, Validation, Statistics, or Risk Management.
• Experience within the medical device industry.
• Experience with combination products or drug-device combination products.
• Experience supporting supplier quality, complaint handling, post-market surveillance, or regulatory reporting activities.

Key Competencies

• Strong interpersonal and communication skills with the ability to engage effectively at all organisational levels.
• Ability to challenge existing practices and influence decision-making while maintaining compliance with quality requirements.
• Strong analytical and problem-solving abilities.
• Excellent organisational and planning skills.
• High level of attention to detail.
• Self-motivated with the ability to work independently.
• Ability to manage multiple priorities in a fast-paced regulated environment.
• Strong risk-based decision-making capability.

Additional Requirements

• Willingness and availability to travel as required.
• Commitment to maintaining the highest standards of quality, compliance, and ethical business conduct.

Benefits

• Hybrid working model.
• Defined contribution pension scheme.
• Private medical insurance for employee and immediate family.
• Life assurance and income protection.
• Educational assistance programmes.
• Performance-related bonus.
• Comprehensive health and wellbeing programme.
• On-site fitness facilities.
• Flexible working hours.
• Paid volunteering leave.
• Free parking.
• Subsidised restaurant/canteen facilities.
• Active sports and social programmes.