careers

Overall responsibility for regulatory submissions of new products to regulatory agencies (US, EU and ROW) and regulatory compliance for existing products. This includes supporting all design control activities, developing regulatory strategy, providing regulatory requirements, supporting the development activities, preparing and submitting new product applications to regulatory agencies and responding to additional information requests.

• Develop regulatory strategy for submissions of new products and changes to existing products
• Support, prepare and coordinate regulatory submissions of new products or changes to existing products.
• Prepare and maintain technical files and general safety and performance requirements
• Coordinate and communicate activities with external consultants and regulatory bodies
• Review DHF documentation to assure compliance with regulatory requirements.
• Review and interpret regulatory requirements during product development and communicate to the project team
• Review of V&V protocols and reports to assure comprehensiveness, accuracy and clarity for regulatory submissions
• Support Risk Management activities
• Create, update and maintain standards list
• Support manufacturing activities related to the product
• Provide requirements for, review and approve product labelling
• Support compliant handling
• Report to regulatory authorities

Memic is looking for Quality Control to join our team.

The Quality Control ensures that the company's products are in compliance with their specifications, the company's policies and international standards and guidance.

• Perform variety of inspection activities including visual, dimensional, mechanical and functional inspections
• Follow established procedures to ensure compliance with procedures, visual aids, purchased specifications, inspection forms, work orders or engineering drawings;
• Perform first article inspections on incoming product;
• Initiate nonconforming material reports for product or raw material found to be out of specification. Assisting with investigation and rework;
• Ensure compliance of quality records and supporting documents with internal procedures and GDP practices
• Review Device History Records and approve products for distribution;
• Provides support for technical and quality issues
• Maintain production equipment
• Participate in internal and external audits

• At least 2 years of experience as Quality Control in the Medical Device Industry
• Prior work experience in a regulated manufacturing environment (ISO 13485, 21 CFR Part 820)
• Basic knowledge and understanding of metrology
• Experience in using mechanical and electronic test equipment (i.e: caliper, snap gauge, pin gauge, DVM, micrometer, etc)
• Ability to read and interpret documentation such as Standard Operating Procedures (SOP), schematics and technical drawings
• Basic computer skills, including basic use of Microsoft Office suite software and NetSuite, or equivalent software
• Good English and Hebrew skills