The ideal candidate is a critical thinker who will proactively improve the quality systems of the company through close collaboration with product engineering, regulatory affairs, and interaction with key partners to ensure safe and effective medical device manufacturing.
- Development and maintenance of RCE Quality Systems and oversight of daily activities performed by the Quality staff
- Steward for Quality Assurance and Quality Control to ensure manufacturing of safe and effective RCE medical devices
- Develop and implement Quality Systems and procedures including SOPs, policies, forms, and reporting tools
- Identify and communicate quality or compliance risks and participate in determination of appropriate plan to address risks
- Serves as official correspondent and primary interface with Competent Authorities and Notified Bodies
- Recruit, hire, and train direct reports needed to accomplish the tasks in the Quality Management function.
- Responsible for the Document Control function and management of QA Controlled documents
- Responsible for the management of validation activities for processes, tests, equipment and facilities to meet industry or regulatory requirements
- Responsible for ensuring that incoming inspection of product is performed in a timely manner and meets all approved procedures and regulatory requirements
- Responsible for managing CAPA programs and ensuring adequate investigation activities are performed and appropriate actions are identified
- Responsible for the supplier qualification program (including the creation of supplier agreements), ensuring site audits are performed when needed, reviewing audit reports/observations and evaluating issues with suppliers
- Review and perform gap analysis on Software Development Lifecycle procedures compliant to IEC 62304
- Responsible administering the MDR and vigilance program and ensuring product complaints are investigated per procedures. Ensure appropriate identification and disposition of product lots related to product complaints based on complaint findings
- Responsible for the management of the Non-Conforming Parts investigation and dispositioning
- Serves as hosts for all audits of all external audits of company's Quality Management System
- Ensures that all internal audits are performed in a timely manner.
- BS or BA in a scientific field
- 5 years of Quality System experience within the medical device industry
- Thorough knowledge of Quality System Regulations for medical device manufacturing, including 21 CFR Part 820, ISO 13485, IEC62304, EU MDD or EU MDR
- Exposure and experience with inspections by regulatory authorities, particularly FDA and Notified Bodies
- Demonstrated ability to apply comprehensive, in-depth, understanding of medical device regulatory compliance requirements with an emphasis on Quality
- Experience working on a medical device with a software component that handles data acquisition, data collection, data transfer from connected device to a cloud based backend, data management on a backend system and data visualization on a front end application (web portal and/or mobile app)
- Preferably, the candidate has also worked on a company developing and managing AI algorithms for regulatory requirements.