Design Quality Engineer - 12 month FTC

Design Quality Engineer – 12 Month FTC

Overview

Our client, a leading multinational medical device organisation, is seeking a Design Quality Engineer to support their Design Quality team on a 12-month fixed-term contract. This role will focus on product risk management, quality engineering support for new product development activities, and ensuring compliance with applicable regulatory and quality standards within a highly regulated environment.

This is an excellent opportunity for an experienced Quality Engineer with strong medical device experience to join a collaborative and fast-paced manufacturing environment.

Key Responsibilities

• Ensure compliance with all applicable regulatory requirements, standards, and internal quality procedures
• Support Quality Engineering activities across New Product Development (NPD) and New Product Introduction (NPI) programs
• Provide support for:
• Test method validation
• Product verification & validation
• Reliability testing
• Statistical data analysis
• Support component qualification, process capability studies, equipment qualification, and process validation activities
• Maintain and support product risk management files in line with ISO 14971 requirements
• Participate in field assurance investigations and post-market surveillance activities
• Collaborate closely with R&D and Engineering teams to support successful product launches and lifecycle management
• Review and approve validation documentation and risk management records
• Participate in internal, external, and regulatory audits
• Support regulatory submissions and continuous improvement initiatives

Candidate Requirements

Qualifications

• Third-level qualification in Engineering, Science, or a related technical discipline
• Minimum 3+ years’ experience within the medical device industry (Class II or III preferred)
• Experience working within a highly regulated environment such as medical devices, pharmaceutical, or life sciences

Technical Experience

• Strong understanding of:
• ISO 13485
• ISO 14971
• MDR/MDD
• MDSAP
• QSR / 21 CFR
• Applicable regulatory and quality standards
• Hands-on experience with:
• Design validation
• Process validation
• Equipment qualification
• Test method validation
• Risk management
• Experience supporting NPD/NPI and product commercialisation activities
• Experience participating in quality and regulatory audits

Skills & Competencies

• Strong analytical and problem-solving skills
• Excellent communication and stakeholder management abilities
• Ability to work effectively in a fast-paced environment
• Self-motivated with a proactive and collaborative approach
• Strong organisational skills with the ability to manage multiple priorities
• Continuous improvement mindset

If you are interested in learning more about this opportunity, please apply with your updated CV.