Quality Assurance Specialist
Precision Neuroscience is pioneering a brain implant, known as a brain-computer interface (BCI), to restore communication and independence for people with neurological conditions. Our cutting-edge technology is designed to empower people with paralysis to control digital devices—such as computers and smartphones—with their thoughts alone, opening new possibilities for daily life.
Precision’s multidisciplinary team brings together leading experts in diverse fields such as neurosurgery, artificial intelligence, machine learning, microfabrication, electrical engineering, and more. We are committed to turning breakthrough scientific advancements into real-world solutions for people affected by conditions such as spinal cord injury, stroke, and ALS.
As a Precision employee, you will be joining one of the fastest moving and best-capitalized companies in the emerging field of BCI. Since our founding in 2021, Precision has secured over $155 million in funding, developed and validated our technology, and initiated human trials in collaboration with some of the nation’s top hospitals.
We are seeking a Quality Assurance Specialist to establish, implement, and maintain Quality processes and policies for Precision Neuroscience. The Quality Team plays a crucial role in the product development cycle, the software development lifecycle, supplier sourcing and development, risk management, and verification and validation, among other activities.
This position will be based in our Santa Clara office. We are unable to consider remote workers or people not currently based in the United States, with working rights.
Key Responsibilities
- Manage an eQMS (including but not limited to Document Control, Training Management, CAPAs, NCs, and other quality records) with some guidance.
- Manage the purchasing process for purchase orders that fall under the QMS.
- Manage and track inventory and quarantined materials that are within Precision’s QMS under guidance from Quality Engineers.
- Support quality team in executing reworks, generating labelling, and qualifying lower-risk suppliers and equipment.
- Support internal and external auditing processes through notetaking and assisting the Quality Director and Engineers in gathering required documentation.
- Support quality system processes including CAPAs, internal audits, NCRs, Supplier Quality and Complaint Handling systems
- Perform additional responsibilities or other functions as assigned.
Skills, Knowledge and Expertise
- BS or more in a relevant scientific discipline.
- A minimum of 1-3 years’ medical device industry experience is necessary (can be internship experience).
- Excellent interpersonal written and verbal communication skills.
Preferred Qualifications:
- Ability to focus on and achieve scheduled milestones, including contingency planning.
- Knowledge and understanding of FDA regulations (21 CFR 820), ISO 13485, and ISO standards related to medical device manufacturing.
- Experience in working with Class II or III medical devices.
- Strong team-working and communication skills. A drive to get the job done in the face of obstacles and time constraints, and a willingness to jump in wherever needed.
Diverse workforces create the best culture, company, and products. We at Precision are committed to an inclusive culture that celebrates the uniqueness and contributions of everyone. As an equal opportunity employer, Precision does not discriminate on the basis of sex, race, religion, national origin, disability status, protected veteran status, or any other characteristic protected by law.
About Precision Neuroscience
Precision is building a direct connection between the human brain and computers, to benefit the hundreds of millions of people worldwide suffering from neurological conditions. Established in 2021, we are a leader in the development and commercialization of brain–computer interfaces (BCI).
As a Precision employee, you will be collaborating with experts across a diverse array of fields–including neurosurgery, mechanical engineering, machine learning, and microfabrication–to push the boundaries of what is possible. You will be joining a well capitalized and fast-moving company. In the two years since Precision’s founding, we have built and validated a product and have begun human trials in partnership with some of the country’s leading neurosurgery programs. And you will be working toward a deeply meaningful goal: restoring function to people living with devastating neurological conditions, including stroke, spinal cord injury, traumatic brain injury, and neurodegenerative disease such as ALS. Our platform will enable these individuals to regain independence, communicate with loved ones, and return to work.
As a Precision employee, you will be collaborating with experts across a diverse array of fields–including neurosurgery, mechanical engineering, machine learning, and microfabrication–to push the boundaries of what is possible. You will be joining a well capitalized and fast-moving company. In the two years since Precision’s founding, we have built and validated a product and have begun human trials in partnership with some of the country’s leading neurosurgery programs. And you will be working toward a deeply meaningful goal: restoring function to people living with devastating neurological conditions, including stroke, spinal cord injury, traumatic brain injury, and neurodegenerative disease such as ALS. Our platform will enable these individuals to regain independence, communicate with loved ones, and return to work.
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