Finnesse Partners has been engaged to search for a Quality Assurance Manager. Our client is an innovative digital health company utilizing healthcare software to develop a cutting-edge platform and has attracted one of the most impressive Board of Directors ever seen in MedTech before. The product is a diagnostic tool for a world health issue that affects ¼ of the population. The Quality Manager will have responsibility for developing and maintaining their Quality Systems in Document Control, Design Assurance, Auditing, Supplier Monitoring, CAPA, and Training Programs. The manager will also be responsible for developing software quality assurance programs used in the development, testing, and documentation of medical device software. Candidates must have in depth experience with IEC 62304, and defining the life cycle requirements for medical device software. Using the set of processes, activities, and tasks described in this standard establishes will aid the Quality Assurance Manager in establishing a common framework for the medical device software life cycle processes.
Direct the Quality Management System (QMS) to ensure all elements meet or exceed ISO 13485, FDA Part 820 QSR and applicable regulatory and statutory requirements.
When the Director, Quality and Regulatory Affairs is not available, the manager is responsible and has the authority to ensure that processes needed for the quality management system are documented; reporting to top management on the effectiveness of the quality management system and the need for improvement; promoting the awareness of applicable regulatory and quality management system requirements throughout the organization.
Oversee the creation, approval, maintenance, and retention of all QMS documents.
Assemble and manage a results-oriented team of Software Quality Engineers and Technicians to assure that the medical device software products being developed meet the design requirements.
Assure that all software documentation meets the expected requirements of global regulatory bodies.
Assure Quality plays a role in new Technology projects supporting such activities as validation, Risk Management, DMR, and Software Development Life Cycle.
Identify trends in quality and drive appropriate actions to establish and communicate Quality KPIs.
Identify, implement and monitor the corrective actions needed to reverse unfavorable trends.
Must have firm knowledge of software quality assurance and medical device software and applicable standards (ISO 62304) and the Software Development Life Cycle.
The Quality Manager must be comfortable with rapid change of direction and concepts on a regular basis and be able to adapt at a moment’s notice.
3+ years of management-level work in Quality Assurance in the medical device industry including the medical device software development and testing. Knowledge of “Software as a Medical Device.
Bachelor’s or Masters’ degree in the sciences; Life Sciences preferred.
Additional Salary Information: depending on qualifications
Internal Number: 1527
About Finnesse Partners
Finnesse Partners is a search and consulting firm dedicated exclusively to the MedTech industry. For over 28 years, Janie Finn and her team have helped MedTech firms find exceptional talent to grow and successfully compete in this demanding marketplace.
Clients who have worked with us over the years know that our core principles of quality, personal relationships and commitment to the MedTech industry are more than just words on a page. This is how we do business. We truly pride ourselves in adding value to our fantastic client organizations and to the careers of so many wonderful candidates placed. Thank you for your trust in us.