About the Role
We are seeking a proactive and detail-oriented Quality Engineer to join our team in ensuring the highest standards of product quality and regulatory compliance within our medical device manufacturing operations. This role is critical to maintaining our commitment to patient safety and product excellence.
Key Responsibilities
Support and maintain the Quality Management System (QMS) in accordance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory requirements.
Conduct root cause analysis and implement corrective and preventive actions (CAPA) for quality issues.
Lead and support internal and external audits, including regulatory inspections.
Collaborate with cross-functional teams to ensure quality standards are met throughout the product lifecycle.
Review and approve manufacturing documentation, including batch records, validation protocols, and change controls.
Monitor and analyze quality metrics to drive continuous improvement.
Provide quality support for sterilisation processes, including validation and routine monitoring.
Apply microbiological principles to assess contamination risks and support environmental monitoring programs.
Required Qualifications & Experience
Bachelor's degree in Engineering, Microbiology, Life Sciences, or a related field.
Proven experience in a medical device or pharmaceutical industry.
Solid understanding of manufacturing environments, preferably cleanroom operations.
Experience with sterilisation processes (e.g., EO, gamma, steam) and associated validation requirements.
Background in microbiology (Deirable)
Familiarity with regulatory standards such as ISO 13485, FDA QSR, and EU MDR.
Strong problem-solving skills and attention to detail.
Excellent communication and documentation skills.
Desirable Skills
Experience with risk management tools (e.g., FMEA, HACCP).
Knowledge of statistical techniques and data analysis.
Proficiency in quality software systems (e.g., TrackWise, MasterControl).Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy