Quality Systems Manager (SAMD)
- Location: Austin, Texas
- Working Situation: Remote
- Level: Mid-Senior Level Manager
Our client, a Mid-Sized, medical device firm, is building out a platform that helps clinicians personalize care with fast, accurate tools for establishing a clear baseline and tracking outcomes over time.
The Manager- Quality Systems (SAMD) will play a critical role responsible for overseeing the company's Quality activities, ensuring compliance with regulations, and implementing an electronic Quality Management System (QMS). The Quality Manager will be key in shaping the future of digital medicine by contributing to the development of objective mental health diagnostics using eye-tracking technology.
The Manager- Quality Systems (SAMD) will:
- Develop and improve specific Quality processes and procedures, including SOPs, Work Instructions, Internal/External Audits, and Management Review.
- Oversee all Quality/QMS training activities, including design controls, risk management, policies, and procedures.
- Create a practical and efficient approach to Quality, considering regulatory requirements and software development needs.
- Act as the primary quality lead with management oversight for project activities and compliance with regulations.
- Monitor compliance with QMS processes and procedures, working with stakeholders to generate and document the required evidence.
- Implement and manage electronic Quality Management System (eQMS).
- Lead the support and execution of internal and external audits.
- Escalate non-compliance issues to Quality and Executive Management.
- Thoroughly review Quality documentation and strategy, providing constructive feedback.
The Manager - Quality Systems (SAMD) has the following qualifications:
- Bachelor's degree in Engineering, Science, or a related profession. An advanced degree is a plus.
- Minimum of 5 years of experience in medical device quality roles, with at least 2 years working with the Software as Medical Device (SaMD) category.
- Demonstrated proficiency with ISO 13485 and FDA Quality System Regulation (QSR) standards.
- Hands-on experience successfully supporting FDA and Notified Body Audits.
- Health Care Plans
- Commuter benefits
- Opportunities for continuing education.