Leonid Kaplan Email & Phone Number

Haifa, Israel

Israel

• Leading engineering projects and change control (ECO / ECR, BOM) activities, including planning and implementation.• Perform design verification testing including data analysis and validation protocols and reports.• Implement and execute packaging qualification activities such as peel & dye test, visual inspection.• Responsible for V&V tests and IQ/OQ/PQ documents for products, jigs, etc...• Lead engineering investigations related to equipment and production line failures, customer complaints, CAPA, etc.• Write and review of company documents, especially DMR files (specifications, work instructions, flow chart, risk analysis, etc.).• Responsible engineer for the maintenance process of all the company equipment.• Work closely with production and logistics teams, interfaces with manufacturing in identifying and correcting quality issues for new and existing product lines.• Define test methods related to product release.• Daily work with subcontractors / manufacturers in Israel and abroad.• Familiar with sampling and statistical control method.• Familiar with ISO 13485, 9001.• Assures compliance to in-house and external specifications and standards.• Maintain quality assurance objectives.• Participate in second- and first-party audits (CE, FDA, ISO13485).

• Responsible for R&D Lab and lab equipment• Responsible for DV, V&V, bench testing and process validation tests including protocols and reports.• Part of Risk management team

Israel