Offer summary

Qualifications:

BSc degree in Engineering or relevant field., Minimum 3 years experience as a QA Engineer in a medical device company., Certified internal auditor with knowledge of ISO19011., Good understanding of medical device regulations like FDA GMP and ISO13485..

Key responsibilities:

Develop and maintain the company's Quality Management System.

Support product development, supply chain, and manufacturing teams with quality activities.

Lead and support CAPA activities and supplier quality management.

Conduct internal audits and support external audits in compliance with standards.

Job description

Description

Augmedics, a medical device start-up developing an Augmented Reality Guided Surgery System, is seeking for a QA Engineer.

The QA Engineer at Augmedics is responsible for developing and maintaining the company’s Quality Management System in accordance with various medical device requirements.

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 supplier’s 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.

Requirements

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.

Required profile