Quality Manager

Company Description

P-Cure Ltd. provides an innovative, compact, and gantry-less adaptive proton therapy system designed to integrate seamlessly into existing radiation oncology departments. By significantly reducing the capital and operational costs, P-Cure empowers treatment centers to expand the availability of life-saving proton therapy. Dedicated to improving global access to cancer care, the company delivers turnkey solutions for cancer institutions and new facility developers worldwide. P-Cure is at the forefront of bending the value curve for proton therapy by making this advanced treatment option accessible and efficient for healthcare providers.

Role Description

This is a full-time, on-site role for a Quality Manager based in Shilat.

Strong background in QA managing in medical device companies (software and hardware) with end to end responsibility over all QA activities spanning R&D and operation with respect to a multidisciplinary Class 2 product. Implementation of MDR (regulation 2017/745) ISO 13485, ISO 14971 & IEC62304, FDA QSR, MDSAP. Ligation with NB and audits management. Planning QA activities. Knowledge and experience with CE submission. 

Responsibilities:

· Leading internal and external audits. Perform internal and suppliers audit and prepare the company for regulatory audits.

· Responsible for all QA activities in the respective client management system including: CAPA, MRB, ECO, training and supplier management.

· Create Quality Metrics and prepare for Management Review.

· Review training and documentation materials for production (e.g., work instructions, verification and validation reports), Design transfer. SQA advantage.

· Maintain design control processes (HW and SW) including risk management.

· Provide guidance and support R&D and Manufacturing.

· Hands on with a capability of expanding a QA department in the future

· Beneficial: prepare and submit regulatory (CE) documentation according to MDR.

Education, Experience, and Skills:

· Academic Degree and Quality education.

· Qualified auditor

· At least 6 years experience as QA manager.

· Experience in writing and maintain DHF related documents.

· Experience in writing and implementing Quality Procedures.

· Knowledge in industry related standards and their interpretation.

· Leading regulatory audits.

· A high level of command of both English and Hebrew. Additional fluencies will be advantageous as well.

· Experience in writing CE dossier submission – beneficial.

· Engineering education – beneficial.