Supplier Quality Engineer and Production Quality Lead

Aspect Imaging, a Global medical high-tech Company located in Shoham, is seeking a Supplier Quality Engineer and Production Quality Lead .The ideal candidate will have a strong quality knowledge throughout product lifecycle especially in production and purchasing activities with aspects of effective management and strategy.

Responsibilities

• Responsible for ensuring the company's products meet defined quality standards such as ISO13485, MDSAP, FDA 21 CFR Part 820.

• Utilize expertise to continually refine QA processes, enhancing efficiency and reducing errors.

• Develop, refine, and implement quality management procedures including Purchasing, Incoming Inspection, Control of Non-conformity, Measuring Equipment etc.

• Train suppliers on company procedures and processes as required.

• Actively participate in internal and external audits.

• Prepare and participate in management reviews.

• Manage production line non-conformities

• Mange and oversee ECO process and implementation related to quality.

• Lead the MRB Exceptions Committee.

• Maintain environments control.

• Provide support for production line validation processes.

• Monitor temperature, humidity, and ESD levels on production and development lines.

• Responsible for Document control approval.

Qualifications

• 3 to 5 years of Class II medical device quality and/or regulatory experience is required.

• Bachelor’s degree preferably in a scientific discipline such as Science, or Engineering

• Minimum 2 years of experience in manufacturing engineering or quality control.

• Familiarity with quality system standards and QSR requirements.

• Knowledge of medical device development and production, vendor quality experience preferred.

• Certification as a Quality Engineer (CQE) is advantageous.

• Strong interpersonal and communication skills with integrity.

• Ability to influence and collaborate positively across functions.

• Willingness to travel as required.

• Able to work independently with minimal instructions/supervision.

• Capable of multi-tasking and rapidly adapting to changing priorities

Please send your C.V to:

[email protected]