Cognito Therapeutics, Inc. is a venture-backed (Morningside Ventures, FoundersX) startup company translating scientific findings from MIT into therapeutic approaches for Alzheimer’s disease and other neurodegenerative conditions. We were awarded a Breakthrough designation by the FDA in December 2020 based upon our phase 2 data that showed preservation of both brain function and structure in Alzheimer's patients. Cognito initiated our pivotal study for first-line treatment of Alzheimer’s in Dec 2022 and expects to start additional clinical studies in Mild Cognitive Impairment (MCI) and Parkinson’s Disease in 2023. We are a fast-moving, highly motivated team of people with the ambitious goal of helping millions of patients and caregivers around the world who are burdened with neurodegenerative conditions. With our patented gamma stimulation technology, we are committed to developing non-invasive device-based therapies.
About the Job
The Quality Engineer develops, establishes, and maintains quality engineering methodologies, systems, and practices which meet Cognito Therapeutics, customer, and regulatory requirements. The individual in this role also serves as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, and company quality goals and priorities.
Roles and Responsibilities
- Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices. Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Supports the development and maintenance of streamlined systems and quality system documentation as part of the Cognito Therapeutics Quality Management System to ensure stakeholder expectations are met.
- Sustains and improves the document control and record retention processes, serve as Document System and Change Administrator.
- Performs gap analyses of product and system documentation in the support of the development and improvement of products and processes.
- Serves as Quality approval for product and process documentation, including but not limited to development plans, functional plans, testing protocols & reports, risk assessments, design reviews, change orders, DHRs, procedures, and work instructions.
- Supports conformance with domestic and international regulations and may assist in providing responses to regulatory agencies with respect to medical device compliance.
- Prepare, support, and ensure the readiness for any potential internal and/or external audits and inspections.
- Any additional activities as assigned by the supervisor.
Who You Are:
- A medical device quality professional with a broad working knowledge of 21CFR820 and ISO 13485.
- A problem solver able to operate in a team environment using formalized tools.
- A self-starter able to work independently and collaboratively in interdisciplinary teams.
- Detail oriented and can lead multiple projects and activities assigned.
- Excellent organizational skills, planning, communication and follow-up skills.
- Bachelor’s degree in Science or Engineering or related subject area.
- 3 years of quality engineering experience in a medical device company, 5+ years preferred.
- Experience with FDA Quality System Regulations and ISO Standards. Working knowledge of MDR is a plus.
- ASQ-certified quality engineer, ASQ-certified quality auditor, and/or Six Sigma/Lean certified, a plus.
- Proficient in Microsoft Word, PowerPoint, and Excel. Experience with PLM/QMS systems a plus