Senior Quality Engineer

We are seeking a motivated and detail-oriented Quality Engineer with 1 to 3 years of experience in a manufacturing or engineering environment. The ideal candidate will support quality assurance activities, ensure compliance with industry standards, and work closely with cross-functional teams to drive continuous improvement. Key Responsibilities: Support implementation and maintenance of the Quality Management System (QMS) in accordance with ISO 13485, FDA 21 CFR Part 820, and other applicable standards. Participate in internal and external audits, including preparation, execution, and follow-up of corrective actions. Investigate non-conformances (NCs), customer complaints, and CAPAs using root cause analysis tools such as 5 Whys, Fishbone, and 8D. Assist in document control, risk management activities (per ISO 14971), and validation of processes and equipment (IQ/OQ/PQ). Work with cross-functional teams (Engineering, Production, R&D) to ensure design and manufacturing processes meet quality standards. Review and approve production records, batch records, and Device History Records (DHRs). Monitor and analyze quality metrics, and contribute to continuous improvement initiatives. Support supplier quality activities including audits, supplier evaluations, and incoming inspection processes.