We are located in Yokneam.
Main responsibilities:
Work closely with the engineering, operations and supply chain teams, both in Israel and the USA, providing ongoing (sustain) product support and supporting NPI activities (e.g., parts and materials specifications, equipment qualification, facility and infrastructure qualification and process controls.
Good mechanical and electrical knowledge to enable conducting process nonconformities investigations and implementation of corrective actions.
Leading and supporting CAPA activities.
Supplier Quality: Approval of new suppliers, analyse suppliers performance, Supplier auditing and SCAR management.
Proactively initiate and support process improvements, through improved process controls, statistical techniques and use of various production related SW tools.
Supporting Computer Software Validation activities both in R&D and production, Understanding 21CFR part11 requirements.
Auditing: Perform internal auditing in accordance with ISO19011 and support all activities related to external audits.
BSc degree in Engineering or relevant field A must.
CQE / CMQ certification An advantage.
Minimum 3 years experience as a QA Engineer in a medical device company – A must
A good knowledge of Medical Device Manufacturers requirements (e.g. FDA GMP per 21CFR Part 820, ISO:13485, MDSAP, and others).
Certified internal auditor A must,
A lead auditor certification An advantage.
In-depth understanding of technical documentation and problem-solving abilities.
Familiarity with statistical analysis.
Knowledge in the requirements for ISMS per ISO27001:2022 An advantage.
Proven experience in leading and managing Corrective & preventive action implementation in a multi-disciplinary medical device.
Highly motivated and self-driven person capable of adjusting quickly to changes, Great attention to details.
Fluent English.
