QA/RA Manager

Responsibilities:

Define, implement, and maintain the effectiveness of the quality management system in the company in compliance with the requirements of ISO 13485, MDR requirements and 21 CFR Part 820. Including:

Responsible for company’s QA requirements compliance and training of team members (for all teams’ activity, including R&D and Marketing) and for the company’s QA records.

Manage and control the processes of nonconforming products/material (including the material review board (MRB)), corrective and preventive actions and customer complaints handling.

Writing and reviewing SOPs, technical protocols, and reports in English

Prepare and implement the internal audit plan.

Evaluate suppliers, subcontractors, external services, etc. on quality issues.

Lead and support Quality Control daily activities, including receiving inspection and final batch and product release to stock.

Manages the review and approval process of all products advertising and labeling to determine compliance with global labeling requirements.

Inspect the company’s production process for manufacturing of commercial products including implying the QC steps throughout the production process, ensuring raw materials meet the company’s quality standards and that equipment and processes follow predetermined quality

Act as management representative responsible for quality management system requirements throughout the organization.

Report to the VP Operation and QA Senior Consultant on the performance of the quality system, including needs for improvement.

Advantageous (optional) - Supporting and coordinating regulatory submissions and registries to FDA (PMA class II device), EU (class III) and other regulatory bodies world-wide per company regulatory strategy.

Experience:

Bachelor’s degree required (preferably in an engineering or chemistry or biotechnology fields, medical synthetic polymers or polymer chemistry or electrospinning techniques or equivalent in work experience).

5+ years of experience in QA/RA positions in a Medial Device company

Solid understanding and proven of ISO 13485, 21 CFR 820 QSR, ISO 14971.

Solid understanding and experience in analytical methos, chemical analysis, and analysis of polymeric and degradable materials

Excellent English and effective verbal communication and writing skills including with American/European advisors.

Advantageous (optional) - Experience in supporting submissions to FDA (510k or PMA) and notified bodies