DescriptionEmpaticaEmpatica is a full-stack, digital healthcare company, forever changing the way health is monitored and new treatments are developed through our AI platform,digital biomarkers, and state-of-the-art medical wearables. Our customers range from some of the world's largest institutions (such as NASA, Harvard University, and top-tier pharmaceutical companies, to name a few), to individual users who message us every day and tell us how our products changed their lives.If you are looking to join a fast-paced growth environment and do meaningful work that can make a true impact in the world, then keep reading.About the roleAt Empatica, the Regulatory and Quality team drives development and implementation of quality processes and procedures needed to build reliable, safe, and effective medical devices. As a Senior Quality Assurance Specialist, you will be a key member of the Regulatory and Quality team, working closely with product development teams and management to foster a culture of quality and ensure compliance with applicable regulatory requirements across the product development cycle. In this role, you will be responsible for supporting continuous improvement of design and development processes, including risk management, human factor evaluation, design control, and verification and validation.As part of the role you will:Maintain up-to-date procedures related to design and developmentWork with development teams and support them in creating compliant Design History FileParticipate in Risk Management ActivitiesWork with SW Quality Engineers to develop compliant Test Protocolssupport Regulatory in the preparation of technical documentation and submissionSome important details:Empatica is an international environment with offices in Europe and the US, and so we conduct all our work in English.We are operating a hybrid model where our employees choose whether to work from home or come to the office.RequirementsAs the ideal candidate for this position, you:Are a native English speaker or proficient in English (minimum C1)Have a strong academic background (BS or MS) in a scientific fieldHave at least 3 years of experience as a Quality Engineer or Quality Assurance Specialist, preferably in a medical device, biotech, or digital health companyHave knowledge and experience working with ISO 13485, IEC 62304, ISO 14971 standards, EU MDR 2017/745 and FDA 21 CFR 820Have a strong understanding of design control processes relevant to software developmentHave a demonstrated history of applying analytical and problem-solving skills in a cross-functional team environmentAre a strong communicator and proficient with technical writing (SOPs, work instructions)PreferredExperience with medical device QMS platformsExperience with start-up culture and growth-stage companiesFamiliarity with SaMD products, digital biomarkers, and wearable medical devices You and Empatica would be a perfect match if you are:A quick learnerFun and easy to work withA hard-working and collaborative team memberA doer, with an excellent execution mindsetAn outstanding planner, with excellent time management and multitasking skillsFocused on quality and excellenceFlexible in terms of working time and ability to travelA problem-solving hustler who can take on any big or small projectPassionate about our products and our missionLife at EmpaticaYou will join a fast-growing, international, and diverse team of 120+ brilliantly talented humans who care passionately about what we do and the difference we are making in the world. You'll get the opportunity to work directly with engineers, data scientists, and designers, across all levels of the organization, no matter their seniority, and learn from the people that built the business and our products.At Empatica, we believe in a work environment that fosters autonomy, mastery, and purpose. We also believe in flexibility, so you will have the opportunity to work remotely in this position. All you need to do is show us that you have skills and that you are a team player. Once you join our team as a Senior Quality Assurance Specialist, you will have full control of your schedule and can decide when you'll work from the comfort of your home or when you'll prefer to mingle with your awesome team members in the office.If you jump on board, we can guarantee it won't be an easy ride, but it will be one of the most rewarding experiences in your career, one that will allow you to learn a lot, have true ownership of your work, and test your whole skillset on multiple projects which are making a real impact on patients all over the world. Read our blog post and find out some reasons why we love working at Empatica.Inclusion & DiversityAt Empatica we embrace diversity and inclusion. We have colleagues from 30 different countries, while more than 50% of our team is women (double the tech average!) We believe this makes Empatica a more exciting and stimulating place to work, and brings different points of view to the table while fostering a spirit of communication, collaboration, and care, where everyone's opinion and thoughts matter.Benefits??Multiple opportunities to be challenged and step up your career in a fast-growth company in one of the hottest areas of techð Competitive salaryð Employee stock options - we want everyone who joins us to own part of the company and our successð? We have offices in Milan City Center and Downtown Boston. And every summer, we hold an amazing beach retreat in Sardinia, Italyð Health Insuranceð??? Gympass membership with access to gyms, online classes, personal training sessions, and nutrition plansð Membership for mental health and wellness platformsð Free healthy lunch every dayð Organic fresh fruitð» Your personal MacBookð Free Kindle and booksð¡ Remote working optionð? Flexible working hoursð§?ð Personal learning and development budgetðª Free cookies, if you deserve themð Much more...Job SummaryID: D48E5967CBDepartment: OperationsType: full time
