Head of Quality

Join us on our mission to democratize access to the abundance of health information in the human eye Here at identifeye HEALTH Inc., we’re pioneering a new branch in diagnostics between laboratory medicine and radiology, that will enable regular non-invasive health monitoring for both ocular and systemic diseases. We believe in empowering the individual by building approachable and intuitive products to provide personalized health insights to each and every patient. Our products are portable, affordable, easy to use and connected devices for early disease detection and monitoring. We are born from 4Catalyzer - a rapidly growing health-tech incubator founded by Dr. Jonathan Rothberg, an award-winning scientist and highly successful serial entrepreneur. We are fostering a culture of technical excellence where you have the opportunity to learn, explore and see your ideas come to life. Joining identifeye HEALTH is the opportunity to redesign the future of healthcare through the power of technology. We are here to solve real-world problems and maximize global impact, motivated by the idea that our products will change lives, including the ones of people you love. What We Live By Prioritize the Patient - We make products that remove barriers between quality care and the people who need it. Data-Driven Decisions - We search for the best solutions; objective, backed by data, and optimized for speed, simplicity and scale. Support Each Other - We celebrate the ideas and contributions of our teammates and recognize that we can only succeed as a team, and when each person feels heard and valued. Simplify - We build intuitive solutions to simplify patient care. What You Will Be Doing The Head of Quality will play a pivotal role in ensuring that the company's medical devices and processes meet FDA regulatory and international requirements, thus safeguarding patient safety, compliance to regulatory requirements and facilitating market access. As part of our team, your core responsibilities will be to: Lead identifeye’s Quality Assurance team, providing regular coaching, mentorship and development opportunities. Manage identifeye HEALTH’s Quality Management System (QMS). Author, review, and approve changes to the QMS. Develop, write, maintain, administer, provide training on, and manage quality systems documents and procedures that can be used effectively and meet FDA and ISO quality system requirements. Manage and improve the internal training program to ensure quality awareness and regulatory compliance knowledge. Provide counsel, training, coaching and interpretation of quality assurance requirements, FDA and other regulatory guidelines or issues to company personnel. Lead the company's ISO and FDA compliance efforts, particularly in the areas of risk management, SDLC, and design control. Ensure the proper integration of QARA procedures and processes within product development, clinical, manufacturing, supply chain, and other relevant departments. Monitor regulatory updates and drive necessary training and procedure/process changes to maintain compliance. Assist in the preparation of regulatory submission documents and support interactions with regulatory agencies. Support development of global regulatory strategies for the introduction of new and modified device platforms. Lead and manage quality system audits, including running regular internal audits and leading the organization through applicable external audits. Represent QARA as the management representative and demonstrate leadership in Management Reviews, Audits, CAPAs, and related compliance activities. Identify and communicate appropriately risks and mitigation strategies associated with quality/regulatory strategies. What We Are Looking For Baseline Skills, Experiences, & Attributes: Bachelor’s degree in life sciences, engineering or a related discipline. 12+ years of progressive experience within quality assurance and regulatory affairs. Experience in building, improving and maintaining FDA and ISO compliant quality management systems. Knowledge and experience with relevant standards: ISO 9001, ISO 13485, IEC 62304, ISO 14971 and 21 CFR 820 (FDA cGMP/QSR), especially pertaining to product development, manufacturing, supplier management, quality control and customer complaints. Proficient in interpreting and applying quality and regulatory requirements to support product development and commercialization. Prior experience with submission of regulatory filings and correspondence with regulatory bodies. Strong understanding of advanced QARA systems, including the establishment of relevant QARA metrics to track performance and compliance. Entrepreneurial, innovative, energetic, hands-on, team oriented, and customer focused, with the ability to think strategically as well as execute project details. Ability to work onsite in our Guilford, CT office. Willingness and ability to travel up to 20%. Preferred Qualifications: Advanced degree in life sciences, engineering or a related discipline. Experience working in a fast paced, small startup environment. Knowledge of Europe Medical Devices Regulation (MDR) CE Marking Regulatory Process. What We Offer Anticipated Salary Range: $150,000 to $180,000 annually. The base salary range represents the anticipated low and high end of the salary range for this position. Actual salaries will vary and may be above or below the range based on various factors including but not limited to work location, operational needs, potential employee qualifications and other considerations permitted by law. The range listed is just one component of our total compensation package for employees. Other rewards may include annual bonuses, equity and program-specific awards. In addition, we provide a variety of other benefits to employees including but not limited to: Fully covered medical insurance plan, and dental & vision coverage. As a health-tech company, we place great worth on our team’s well-being. 401(k) plan. Everyone should be encouraged to save for their retirement adventures Flexible PTO policy and remote/hybrid work arrangements. We believe in taking personal responsibility for managing our own time, workload and results. Free onsite meals & kitchen stocked with snacks at our office locations. Annual "Improve Your Work Environment" stipend. We support what you need to be your best self when at work Professional development reimbursement. Let's grow together More exciting employee perks... but most importantly, the opportunity to build a revolutionary healthcare product and save millions of lives identifeye HEALTH Inc. does not accept agency resumes. identifeye HEALTH Inc. is an E-Verify and equal opportunity employer regardless of race, color, ancestry, religion, gender, national origin, sexual orientation, age, citizenship, marital status, disability or Veteran status. All your information will be kept confidential according to EEO guidelines. Apply for this job * indicates a required field #J-18808-Ljbffr