Novel: Q.A and regulation Manager JB- 177
The Quality Assurance Manager will report directly to company General Manager and will work closely within project teams (and in some cases independently) contributing technical leadership/knowledge capabilities.
This position will contribute to the review of design process, production engineering and production activities. This position will interact with project management, HW and SW teams and other company technical departments and subcontractors on regular bases. Responsibilities will include, but not be limited to the following:
- Implementing and maintaining Quality Management System (QMS), that complies with ISO 13485, ISO 14971 and FDA 21 CFR Part 820
- Develop, administer and maintain quality assurance procedures and activities required to ensure that the company’s processes and products are in compliance with applicable quality standards and requirements.
- Review and control SW testing process of E.S.I Novel products., implement, execute, root cause analysis and implementation of corrective action for process related concerns.
- Interface with Engineering, Operations and Product Management to design and implement appropriate verification methodology and documentation supporting release of products (alpha, beta, final)
- Support the quality inspection to ensure projects, products and processes comply with the relevant requirements of the QMS
- Analyze failure, corrective and preventive action to respond to internal/external customer complaints.
- Create and maintain company quality documentation, such as manuals, procedures, etc.
- Continuously improve QA processes and procedures.
- Preparation of QA report.
- Able to design plan manage and lead cross-company process.
Essential Skills and Experience:
- Minimum BS/BA in business management or a science discipline (electronic engineering as advantage).
- 5+ years of experience implementing test strategies, process validation and verification in FDA-compliant medical device industry.
- Demonstrated success in a start-up, entrepreneurial work environment.
- Thorough knowledge of FDA Quality System requirements, ISO 13485:2003 (Quality System) requirements, ISO 14971 (Risk Management) requirements, Medical Device Directives (MDD) requirements, Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards
- Familiar with EN 60601, Safety requirements for medical electrical systems and ISO 62304, Medical Device Software – Software Life Cycle processes.
- 4 or more years of experience with QMS implementation that complies with FDA 21 CFR Part 820, ISO 13485 and ISO 14971 standards
- Lead role (administrative or technical) in one or more FDA or other Worldwide medical authority’s submissions for approval of a medical device as advantage.
- Project management skills and proficiency and analysing and interpreting test data.
- Ability to use word processing and database applications as well as various software programmes such as Excel and PowerPoint
- Familiar with PLM systems (Agile PLM /PDM system as advantage).