Quality Engineer at Cognito Therapeutics

Cambridge, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

26 Dec, 25

Salary

0.0

Posted On

27 Sep, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Engineering, Regulatory Compliance, Documentation Management, Problem Solving, Attention to Detail, Communication, Design Controls, ISO Standards, FDA Regulations, Audit Preparation, Team Collaboration, Project Management, Change Management, PLM Systems, Microsoft Office, Six Sigma

Industry

Medical Equipment Manufacturing

Description

Company Description Cognito Therapeutics, Inc. is a venture-backed (Morningside Ventures, FoundersX, IAG, Starbloom) late clinical stage company translating scientific findings from MIT into therapeutic approaches for brain health, including Alzheimer’s disease and other neurodegenerative conditions. We were awarded a Breakthrough designation by the FDA in December 2020 based upon our feasibility data that showed our therapy’s strong safety profile and a notable preservation of cognition and function in patients with mild-to-moderate Alzheimer’s. We completed enrollment in our pivotal study, HOPE, in June 2025 and expect to release topline data from the trial in summer 2026. We are a fast-moving, highly motivated team of innovators with the ambitious goal of helping millions of patients and caregivers around the world who are impacted by neurodegenerative conditions. With our patented brain stimulation technology, we are committed to developing convenient, safe and effective neuroprotective therapies to improve brain health and well-being for all. 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 · Quality Leadership Extraordinaire: Be the driving force behind quality disciplines, decisions, and practices. You'll utilize your systematic problem-solving skills to identify, prioritize, communicate, and resolve quality issues. · Documentation Dynamo: Support the development and maintenance of streamlined systems and quality system documentation within the Cognito Therapeutics Quality Management System. Your keen eye for detail will ensure that stakeholder expectations are not only met but exceeded. · Guardian of Product Documentation: Take the lead in approving product documentation, from development plans to testing protocols and reports, ensuring they meet the highest quality standards. · Innovation Advocate: Perform gap analyses of product and system documentation, contributing to the continuous improvement of products and processes. · Document Control Virtuoso: Elevate our document control and record retention processes while serving as the Document System and Change Administrator. · Regulatory Rockstar: Ensure our compliance with domestic and international regulations and play a pivotal role in responding to regulatory agencies on medical device compliance. · Audit Adept: Prepare, support, and ensure readiness for internal and external audits and inspections. · Dynamic Collaborator: Embrace additional activities as assigned by your supervisor, adding your expertise to diverse projects. Who You Are – The Quality Champion We Seek · Regulatory 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 Perfectionist: 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 · Educational Excellence: A Bachelor's degree in Science or Engineering or a related field is your foundation. · Experience Extraordinaire: You bring 3+ years of quality engineering experience in a medical device company to the table, with 5+ years preferred. Experience as a Quality representative that successfully developed and launched a new product sets you apart. · Regulatory Wizardry: Your familiarity with FDA Quality System Regulations, ISO Standards, and expertise in Design Controls/Product Realization processes compliant with ISO 13485, IEC 62304, and ISO 14971 are your strengths. Knowledge of MDR is a plus. · Certification Champion: ASQ-certified quality engineer, ASQ-certified quality auditor, and/or Six Sigma/Lean certified? You're ahead of the game. · Tech-Savvy Guru: Proficiency in Microsoft Word, PowerPoint, and Excel is a given. Experience with PLM/QMS systems is an added advantage. Join Us in Shaping the Future of Healthcare If you're ready to take your career to new heights and play a pivotal role in revolutionizing medical device quality, Cognito Therapeutics is the place for you. Join us, and together, we'll redefine what's possible in healthcare innovation. Apply today and be part of the Cognito Therapeutics journey towards a healthier future!

Responsibilities

As a Quality Engineer, you will drive quality engineering methodologies and practices that meet regulatory requirements and exceed customer expectations. You will lead quality initiatives, manage documentation, ensure compliance, and prepare for audits.