Quality Engineer

Company Description
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.
Are you ready to embark on a thrilling journey in the heart of Boston, MA, and revolutionize the treatment of Alzheimer's Disease? At Cognito Therapeutics, we're on a mission to make a significant impact on Alzheimer's treatment, and we're seeking a Quality Engineer to join our dynamic team.
About the Job
As a Quality Engineer at Cognito Therapeutics, you'll be at the forefront of innovation, driving Quality Engineering methodologies, systems, and practices that not only meet regulatory requirements but also exceed customer expectations. Your role will be pivotal in enhancing the quality initiatives that support our company's goals and priorities, making you an essential part of our success.
Roles and Responsibilities - Unleash Your Quality Prowess

• Be the driving force behind quality disciplines, decisions, and You'll utilize your systematic problem-solving skills to identify, prioritize, communicate, and resolve quality issues.
• Support the development and maintenance of streamlined systems and quality system documentation within the Cognito Therapeutics Quality Management Your keen eye for detail will ensure that stakeholder expectations are not only met but exceeded.
• Take the lead in approving product documentation, from development plans to testing protocols and reports, ensuring they meet the highest quality standards.
• Perform gap analyses of product and system documentation, contributing to the continuous improvement of products and processes.
• Elevate our document control and record retention processes while serving as the Document System and Change Administrator.
• Ensure our compliance with domestic and international regulations and play a pivotal role in responding to regulatory agencies on medical device compliance.
• Prepare, support, and ensure readiness for internal and external audits and
• Embrace additional activities as assigned by your supervisor, adding your expertise to diverse projects.

Who You Are - The Quality Champion We Seek

• Medical Device Maestro: You are a medical device quality professional with a deep understanding of 21CFR820 and ISO 13485. Your experience with Design Controls/Product Realization processes sets you apart.
• Problem-Solving Dynamo: You thrive in team environments and tackle challenges using formalized tools.
• Self-Starting Trailblazer: You can work independently while seamlessly collaborating in interdisciplinary teams.
• Detail-Oriented Leader: Your organizational skills, planning abilities, and attention to detail are second to none. You excel in leading multiple projects and activities.
• Communication Maven: Your excellent communication and follow-up skills are your secret weapons.

Qualifications - Your Pathway to Success

• A Bachelor's degree in Science or Engineering or a related field is your
• You bring 3+ years of Quality Engineering experience in a medical device company to the table, with 5+ years preferred.
• Your familiarity with FDA Quality System Regulations, ISO Standards, and expertise in Design Controls/Product Realization processes are your Knowledge of MDR is a plus.
• ASQ-certified Quality Engineer, ASQ-certified quality auditor, and/or Six Sigma/Lean certified? You're ahead of the game.
• Proficiency in Microsoft Word, PowerPoint, and Excel is a Experience with PLM/QMS systems is an added advantage.

Join Us in Shaping the Future of Alzheimer's Treatment
If you're ready to take your career to new heights and play a pivotal role in a revolutionary medical device therapy, Cognito Therapeutics is the place for you. Join us, and together, we'll redefine what's possible.
Apply today and be part of the Cognito Therapeutics journey!