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
1. Assist in risk management activities including process FMEAs and hazard analysis.
2. Support compliance with regulatory standards such as ISO 13485, ISO 9001, GMP, and FDA 21 CFR Parts 820 & 803.
🤝 Cross-Functional Collaboration
3. Work closely with R&D, Manufacturing, Regulatory, and Supply Chain teams to embed quality throughout the product lifecycle.
4. Participate in cross-functional teams to support process improvements and resolve quality issues.
🚀 Product Lifecycle & Validation
5. Contribute to validation protocols (IQ/OQ/PQ) for new and existing products and processes.
6. Support test method validation and ensure critical-to-quality (CTQ) attributes are defined and controlled.
🔧 Quality Engineering Activities
7. Assist in statistical analysis, sampling plans, and capability studies.
8. Help maintain and review Quality Control Plans and Design History Files (DHF).
9. Support internal and external audits.
📈 Process Improvement
10. Apply structured problem-solving tools such as Lean and Six Sigma (training provided).
11. Identify opportunities for efficiency and quality improvements.
📝 Non-Conformance & CAPA
12. Support investigations into non-conformances and customer complaints.
13. Assist in developing and implementing corrective and preventive actions (CAPAs).
🔄 Change Control & Post-Market Surveillance
14. Participate in product and process change control activities.
15. Help monitor product performance post-launch using data-driven approaches.
📚 Quality System & Documentation
16. Maintain quality system documentation and contribute to continuous improvement initiatives.
17. Promote a culture of quality and compliance across the organization.
Skills & Qualifications
18. Degree in Engineering, Science, or a related discipline.
19. Strong interest in quality assurance and medical device manufacturing.
20. Basic understanding of quality systems and regulatory standards (training provided).
21. Familiarity with statistical tools (Excel required; MINITAB is a plus).
22. Excellent communication and interpersonal skills.
23. Analytical mindset with attention to detail.
24. Exposure to Six Sigma, Lean, or quality core tools is desirable.
25. Enthusiastic team player with a willingness to learn and grow.