Quality Assurance Manager
About The Position
The Quality Assurance Manager is responsible for the establishment and maintenance of the company’s quality management system, procedures, and quality standards.
Responsible for setting up quality environment, which requires strong understanding of the software life cycle and ability to work closely with the Head of Operations and R&D. Including conducting production inspections and final product release.
Provides leadership and support for the development and implementation of continuous improvement activities throughout the organization.
Ensures Quality system performance is measured and routinely reported to executive management.
The QMS manager will work both independently, and in some cases closely to project teams, clinical, regulation and R&D.
Responsibilities will include, but are not limited to the following:
- Implementing and maintaining Quality Management System (QMS), that complies with ISO 13485:2016, ISO 27001, GDPR, HIPAA 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. Continuous improvement of QA processes and procedures.
- Root cause analysis and implementation of corrective action for process related concerns.
- Analyze failures, corrective and preventive actions to respond to internal/external customer complaints.
- Interface with Engineering, Operations and Product Management to design and implement appropriate verification methodology and documentation supporting release of products
- Support the quality inspections to ensure projects, products and processes comply with the relevant requirements of the QMS
- Planning Company Training and implementation as required by the Quality management system
- Responsible for the planning and implementation for company External audits by 3rd party (CE and FDA)
- Conducting management reviews, collection and data analysis
- Management of the Risk Management process
- At least 10 years of experience in Quality and Regulatory Compliance function in Medical Devices industry;
- 7+ years of experience implementing test strategies, test plans and test cases for software validation and verification in FDA-compliant medical device industry
- 7+ years of experience with QMS implementation that complies with FDA 21 CFR Part 820, ISO 13485, ISO 62304 and ISO 14971 standards
- 5+ years of experience in verification/validation of web-based client/server products incorporating scalable data acquisition, processing, management, and reporting functionalities.
- Demonstrated success in a start-up, entrepreneurial work environment
- Thorough knowledge of FDA Quality System requirements, ISO 13485:2016 (Quality System) requirements, ISO 27001, 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
- Familiar with ISO 62304, Medical Device Software – Software Life Cycle processes
- Lead role (administrative or technical) in one or more FDA audits for review of a medical device
- Experience with automated tools supporting regression and load testing.
- Experience with Microsoft-based tools.
- Project management skills and proficiency and analyzing and interpreting test data
- BS/BA in computer technology or relvant science discipline
- Excellent English reading, writing and oral communication skills