Graduate Quality Engineer - Advanced Wound Care
Department: Quality Engineering
Reports to: Quality Manager
Type: Full-Time, Graduate Role

Position Overview

As a Graduate Quality Engineer, you will play a key role in supporting quality initiatives across product development, manufacturing, and compliance. This is a hands-on role offering exposure to cross-functional teams and real-world applications of quality engineering principles. You'll be mentored by experienced professionals and contribute to projects that improve patient outcomes and product performance.

Key Responsibilities

🛡️ Risk Management & Compliance

• Assist in risk management activities including process FMEAs and hazard analysis.
• Support compliance with regulatory standards such as ISO 13485, ISO 9001, GMP, and FDA 21 CFR Parts 820 & 803.

🤝 Cross-Functional Collaboration

• Work closely with R&D, Manufacturing, Regulatory, and Supply Chain teams to embed quality throughout the product lifecycle.
• Participate in cross-functional teams to support process improvements and resolve quality issues.

🚀 Product Lifecycle & Validation

• Contribute to validation protocols (IQ/OQ/PQ) for new and existing products and processes.
• Support test method validation and ensure critical-to-quality (CTQ) attributes are defined and controlled.

🔧 Quality Engineering Activities

• Assist in statistical analysis, sampling plans, and capability studies.
• Help maintain and review Quality Control Plans and Design History Files (DHF).
• Support internal and external audits.

📈 Process Improvement

• Apply structured problem-solving tools such as Lean and Six Sigma (training provided).
• Identify opportunities for efficiency and quality improvements.

📝 Non-Conformance & CAPA

• Support investigations into non-conformances and customer complaints.
• Assist in developing and implementing corrective and preventive actions (CAPAs).

🔄 Change Control & Post-Market Surveillance

• Participate in product and process change control activities.
• Help monitor product performance post-launch using data-driven approaches.

📚 Quality System & Documentation

• Maintain quality system documentation and contribute to continuous improvement initiatives.
• Promote a culture of quality and compliance across the organization.

Skills & Qualifications

• Degree in Engineering, Science, or a related discipline.
• Strong interest in quality assurance and medical device manufacturing.
• Basic understanding of quality systems and regulatory standards (training provided).
• Familiarity with statistical tools (Excel required; MINITAB is a plus).
• Excellent communication and interpersonal skills.
• Analytical mindset with attention to detail.
• Exposure to Six Sigma, Lean, or quality core tools is desirable.
• Enthusiastic team player with a willingness to learn and grow.

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.