Quality Engineer

This role will ensure the highest level of product quality, compliance with industry standards, and continuous improvement in processes from an engineering perspective.
He or she shall document and record all processes and procedures to ensure compliance to QMS and regulatory requirements

DUTIES:

Regular Duties:
1. Design and Development
*Quality assurance support in the design and development of medical device products, facilitating the application of design/change controls, risk management, quality plan, and implementation of design and development plan
*Champion change management process, document engineering change orders and conduct risk assessment activities to ensure changes to products are developed and manufactured in accordance with applicable industry standards, regulatory requirements, and customer requirements.
*Assist in developing and maintaining design history record
*Prepare and maintain specification records of new components: raw materials and in-process components that are to be approved in the quality plan
*Develops, document, and validates inspection and test methods to support design control, in-process inspection, and final inspection activities utilizing knowledge in engineering fields

2. Management Operations & Quality Management
*Collaborate with the head of operations and the remote team to create a compliant manufacturing environment for assembling and storing electronic medical devices, specifically therapy lasers and its components.
*Contribute to multiple processes at various production stages, including manufacturing assessment, process improvements (CAPA), and NCR investigations
*Participate in risk management meetings and verify risk mitigation implementation in products and processes.
*Conduct internal quality audits.
*Participate in third-party audits and inspections (ISO, Notified Body, FDA,etc)
*Provides Quality Engineering support for commercial Medical products.Provides QA support for internal Quality Systems growth.

3. Validation and Equipment
*Lead Process and Software Verification and Validation Activities according to the validation master plan
*Develop and improve maintenance and calibration plan to ensure timely calibration of equipment in production.