Quality Assurance Engineer

A quality engineer in medical device manufacturing plays a crucial role in ensuring that products meet the required quality standards and comply with regulatory requirements. The Quality Engineer is responsible for maintaining and improving the quality of medical devices by implementing quality assurance processes, conducting inspections and audits, and ensuring compliance with industry standards and regulations. This role involves working closely with manufacturing teams, design engineers, and regulatory affairs to ensure that products are manufactured according to the highest quality standards to ensure quality is maintained at every product lifecycle state, from development through manufacturing and distribution.

5-7 years of experience in quality engineering in Production environments HLA (High Level Assembly)

• Advantage - Medical device/ Defense industry experience (HLA, capital equipment).
• Deep understanding of production processes from Incoming Inspection through assembly, in-process testing, functional Jigs, Final Integration and OQC (Outgoing Quality Check).
• Deep understanding of manufacturing processes (e.g., machining, sheet metal processing, plastic manufacturing, PCB/PCBA and cables).
• Education: Engineer/ Practical Engineer in the field of machinery / Industrial/ materials/ chemical/ biotechnology or another related field - mandatory.
• Strong understanding of working in medical device regulation environment (ISO 13485, FDA QMSR, and risk management standards (ISO 14971)).
• Technical writing skills, in English, that include quality procedures, test plans, PFMEA etc.