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About Us

Senseye is a NeuroTechnology Company in Austin, TX, on the cusp of revolutionizing Mental Health. Over the past six years, we have invested millions of dollars in R&D to build our platform, allowing us to measure cognitive activity via the eye through mobile phones. Through multiple iterations and use cases, we are now focused on building the world's first Objective Mental Health Diagnostics on top of our core technology. Our first diagnostic is for PTSD and is entering clinical trials now, followed by additional indications for Anxiety and Depression. As the world struggles with a mental health crisis, it is not hyperbolic to suggest that an objective diagnostic platform that gives clinicians a safe and objective, accurate approach to identifying and monitoring mental health disease will redefine how mental health services are provided and will enable access to treatment for millions of sufferers. The Senseye platform could be the technology that drives this change. This is an excellent opportunity to shape the future of digital medicine and address unmet medical needs that affect billions of people worldwide.

What we are looking for:

The Quality Manager will be responsible for overseeing Senseyes Quality activities including supporting cross-functional project teams, implementing an electronic Quality Management System (QMS), and ensuring compliance with regulations including FDA QSR and ISO 13485. You will own and support key QMS processes including audits, training, document management, design controls, risk management, software verification & validation (V&V), and ongoing maintenance and compliance activities. You will be at the forefront of making tactical and operational quality decisions that directly impact the companys success, and play a key role in interacting across the organization to communicate quality requirements and strategies for meeting them.

This role is instrumental in supporting Senseyes growth and success and it requires an individual who is highly detail-oriented and able to think outside the box to find creative solutions to challenges. A motivated, enthusiastic, and self-starter attitude is a must! This is an opportunity to get in on the ground floor of building a QMS that is functional, effective, and pragmatic.

Key Responsibilities:

• Create, support, and improve specific Quality processes and procedures, including SOPs, Work Instructions, Internal/External Audits, Management Review.
• Oversee all Quality/QMS training activities including design controls, risk management, policies, and procedures.
• Develop a practical and efficient approach to Quality taking into consideration regulations and software development requirements.
• Serve as the primary quality lead with management oversight for project activities and compliance with regulations.
• Monitor Senseyes compliance with QMS processes and procedures, working with stakeholders to generate and document the required evidence.
• Implement and own Senseyes eQMS.
• Lead the support and execution of internal audits and external audits.
• Escalate non-compliance to Quality and Executive Management.
• Diligently and thoroughly review Quality documentation and strategy, including procedures and reports, and provide constructive feedback.
• Support other Quality and Regulatory tasks as required.

Requirements

• Bachelors degree in Engineering, Science, or a related profession. Advanced degree is a plus.
• At least 5 years of experience in medical device quality roles, with at least 2 years working with the SaMD (Software as Medical Device) category.
• Hands-on experience working with and managing eQMS systems. Prior experience with Greenlight Guru QMS platform is preferred.
• Excellent attention to detail is a must.
• Demonstrated proficiency with ISO 13485 and FDA QSR standards.
• Hands-on experience successfully supporting FDA and Notified Body Audits.
• Extensive knowledge of medical terminology.
• Expertise in international quality frameworks, for example MDSAP (Medical Device Single Audit Program) that is developed and used by a group of international regulators, including the US FDA, Health Canada, Australia's TGA, Brazil's ANVISA, and Japan's MHLW/PMDA.
• Ability to effectively work independently and with teams.
• Excellent verbal and written communication skills plus computer proficiency (e.g., word processing, spreadsheets, eQMS systems).
• Desire and ability to work in a small company environment, with a passion to wear multiple hats and continuously learn and improve.
• Certification(s) in Quality strongly preferred (e.g., CQE, CSQE, CMDA, CQA, etc.)

Benefits

• Competitive salary and stock option plan
• Flexible paid time off (vacation, sick leave, and public holidays)
• Flexible schedules
• Company health care plan
  • Medical, dental, and vision insurance
  • Short and long term disability insurance
  • Life insurance policy
• 401k
• Commuter benefits for parking, public transit, carshares, etc.
• Mothers' room
• Fully stocked kitchen
• Opportunities for continuing education