Sr. Quality Assurance Specialist

<h3>Empatica</h3>Empatica is a full-stack, digital healthcare company, forever changing the way health is monitored and new treatments are developed through our<a href="https://www.empatica.com/en-gb/platform/" rel="nofollow noreferrer noopener"> AI platform,</a> <a href="https://www.empatica.com/en-gb/biomarkers/" rel="nofollow noreferrer noopener">digital biomarkers</a>, and state-of-the-art <a href="https://www.empatica.com/en-gb/embraceplus/" rel="nofollow noreferrer noopener">medical wearables</a>. 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 <a href="https://www.ted.com/talks/rosalind_picard_an_ai_smartwatch_that_detects_seizures?language=en" rel="nofollow noreferrer noopener">changed their lives</a>.<p><br/>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.</p><p><br/></p><h3>About the role</h3><p>At 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.</p><p>As part of the role you will:<br/></p><ul> <li>Maintain up-to-date procedures related to design and development</li> <li>Work with development teams and support them in creating compliant Design History File</li> <li>Participate in Risk Management Activities</li> <li>Work with SW Quality Engineers to develop compliant Test Protocols</li> <li>support Regulatory in the preparation of technical documentation and submission</li> </ul><p></p><p><strong>Some important details:</strong><br/></p><ul> <li>Empatica is an international environment with offices in Europe and the US, and so we conduct all our work in English.</li> <li>We are operating a hybrid model where our employees choose whether to work from home or come to the office.</li> </ul><p><strong>Requirements</strong></p><p>As the ideal candidate for this position, you:<br/></p><ul> <li>Are a native English speaker or proficient in English (minimum C1)</li> <li>Have a strong academic background (BS or MS) in a scientific field</li> <li>Have at least 3 years of experience as a Quality Engineer or Quality Assurance Specialist, preferably in a medical device, biotech, or digital health company</li> <li>Have knowledge and experience working with ISO 13485, IEC 62304, ISO 14971 standards, EU MDR 2017/745 and FDA 21 CFR 820</li> <li>Have a strong understanding of design control processes relevant to software development</li> <li>Have a demonstrated history of applying analytical and problem-solving skills in a cross-functional team environment</li> <li>Are a strong communicator and proficient with technical writing (SOPs, work instructions)</li> </ul><p><strong>Preferred</strong><br/></p><ul> <li>Experience with medical device QMS platforms</li> <li>Experience with start-up culture and growth-stage companies</li> <li>Familiarity with SaMD products, digital biomarkers, and wearable medical devices </li> </ul><p><br/></p><p>You and Empatica would be a perfect match if you are:<br/></p><ul> <li>A quick learner</li> <li>Fun and easy to work with</li> <li>A hard-working and collaborative team member</li> <li>A doer, with an excellent execution mindset</li> <li>An outstanding planner, with excellent time management and multitasking skills</li> <li>Focused on quality and excellence</li> <li>Flexible in terms of working time and ability to travel</li> <li>A problem-solving hustler who can take on any big or small project</li> <li>Passionate about our products and our mission</li> </ul><h3><br/></h3><h3>Life at Empatica</h3><p>You 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.</p><p>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