Quality Engineer

We are supporting a confidential search for a Quality professional with experience in regulated manufacturing environments.
The ideal candidate will have a strong hands-on operational profile, with experience supporting production, investigating nonconformities, performing root cause analysis, managing CAPA/NCMR activities, supporting audits and validations, and driving continuous improvement.
Key experience and knowledge:
Regulated manufacturing experience, ideally in medical devices, dental, pharmaceutical, medical electronics, advanced manufacturing, or high-volume operationsISO 13485, GMP/BPM, FDA QMSR / 21 CFR Part 820CAPA, NCMR, change control, documentation, audits, validation, and risk analysisProblem-solving tools such as 5 Why, Ishikawa, Pareto, 8D, A3 or DMAICpFMEA, control plans, traceability, and nonconforming product managementProcess/equipment/method validationQuality data analysis, SPC, trends, dashboards, and metricsIntermediate to advanced Excel; Power BI, Minitab, JMP, QI Macros or SigmaXL are a plusIntermediate to advanced English preferred
We are looking for someone who can combine technical rigor, practical decision-making, strong communication, sense of urgency, and a collaborative approach in a fast-paced manufacturing environment.