Motif Neurotech
Quality Lead
Houston, Texas, United States · Full-time
No sponsorshipDetected 54 days ago
Intellectual PropertyFDA RegulatoryMedical DevicesLeadership
About the role
- Motif is a medical device startup based in Houston, Texas.
- Motif's technology stack consists of a small implant that is wirelessly powered via magnetic fields from an external wearable transmitter, configured and controlled from a programming interface.
- If yes to the above, then come work with Motif!
Responsibilities
- Own and continuously improve Motif's quality management system
- Partner with Engineering, Clinical, Manufacturing, and Regulatory to define new procedures as the business evolves, and rightsize existing ones to reduce risk and friction
- Drive automation and tooling improvements that streamline the interfaces between QMS processes and the systems people use day to day
- Conduct and facilitate internal and external audits to ensure the quality system is functioning as designed
- Build and maintain a high-quality supplier base
- Partner with Engineering to ensure Design History File integrity, and with Clinical to ensure procedures support compliant study execution
- Facilitate the core quality processes - NCR/CAPA disposition, risk management, document review and approval, and Device History Record / Lot Release sign-off
- Maintain the system of record for training and partner with functional managers to define team-level training needs and monitor compliance
- Serve as the internal culture carrier for quality - a systems thinker who helps the team build quality in rather than inspect defects out
- Partner with Regulatory to ensure quality processes facilitate compliance with regulatory requirements and adopted standards
Requirements
- Experience directly managing quality teams and a track record of partnering effectively with engineering, manufacturing, clinical, and regulatory functions
Nice to have
- Experience in early stage companies and scaling a quality system in conjunction with organization growth and clinical phases
- Quality leadership experience at a startup or first-of-kind device company taking a product through IDE and into clinical study
- Participation in our 401k plan
- The chance to work with an incredible group of people working towards a common goal for a better future
Benefits
- We are designing and developing minimally invasive electronic solutions for serious mental health conditions.
- Powered by our patent-pending methods for wireless power and data transmission, our goal is to create the smallest implantable brain stimulator to treat people with mental health disorders.
- Familiarity with software-of-medical-device standards (IEC 62304) and combination product or sterile packaging quality requirements
- Medical, dental, and vision insurance for you and your dependents
Company info
- Do you believe openness and honesty are key to team success?
- Do you enjoy learning and are curious about how and why things work?
- Do you like challenging the conventional way of doing things to find efficiencies and new ways of working?
- We are an early-stage startup with funding from venture capital firms, grants, and private angel and founder investments.
- We are currently completing the development of our first minimally invasive neural stimulation system and preparing for future versions with additional functionality based on our platform technology.
Equal opportunity
- equal opportunity employer.
Visa & Work Authorization
- Motif Neurotech hires only individuals who are authorized to work in the United States.
- At this time, visa sponsorship is not offered for this role.
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This listing is sourced directly from Motif Neurotech's careers page and normalized into a canonical job model.