Quality Assurance Manager Bardi

Quality Assurance Manager
Bardi
Emilia Romagna, Bardi

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 worlds 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 roleIn the Regulatory and Quality Team, we are responsible for maintaining the company Quality Management System, and related product and system certification, develop regulatory strategies that ensure products compliance with the applicable regulatory requirements, support internal stakeholders in ensuring compliant workflows, as well as supporting management in the optimisation of internal workflows. As a Quality Assurance Manager you will be a key member of the team, supporting the monitoring and maintenance of the Quality Management System, serve as quality representative in product development teams, proposing improvements to internal processes, and providing advice on quality related requirements to other departments. In addition, working together with other internal teams including Operations, Hardware, Data, Software, and Firmware development you will:

Maintain Empaticas Quality Management System up to datePerform Internal AuditCreate validation protocols for our products and production toolsInvestigate and troubleshoot product or production issuesDevelop corrective and preventive actionsSupport Research and Development teams by providing quality guidance to ensure compliance through all stages of new product development and entry into new marketsSupport the validation effort of product and processes within EmpaticaSome important details:

Are a native English speaker or proficient in English (minimum C1) Have a strong academic background, BS or MS in Biomedical EngineeringHave at least 2 years experience as a Quality Engineer or Quality Assurance preferable in a company that designs/manufactures medical devices, wearable devices or IoT devicesStrong analyticaland problem solving skillsHave knowledge and experience working with ISO standards and FDA 510(k) clearance processExcellent project management skillsExperience coding and using QA software tools is a plusHave a passion for Empaticas products and missionHave resilience, a get-things-done attitude, and an innate desire to do great workLife at EmpaticaYou will join a fast-growing, international, and diverse team of 80+ talented people who care passionately about what we do and the difference we are making in the world.

Youll get the opportunity to work directly with colleagues across all levels of the organization, no matter their seniority, and learn from the people that built the business and our products. 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 helping thousands of people worldwide. 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 21 different countries, while 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 everyones 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 tech Competitive salary Employee stock options - we want everyone who joins us to own part of the company and our success We have offices in Milan City Center and Downtown Boston.

And every summer, we hold an amazing beach retreat in Sardinia, Italy Gympass membership with access to gyms, online classes, personal training sessions, and nutrition plans Membership for mental health and wellness platforms Free healthy lunch every day Organic fresh fruit Your personal MacBook Free Kindle and books Remote working option Flexible working hours Personal learning and development budget Free cookies, if you deserve them Much moreJob SummaryID:

3A046D31E6Department:

OperationsType:

full time