Customer Quality Assurance Specialist

Empatica

Empatica 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 role

As a Customer Quality Assurance Specialist at Empatica, you will be a key member of the team, supporting the maintenance of our Quality Management System as well as:

• Work with our Business Development team in handling prospective customers’ quality and regulatory questions
• Support our Clinical Operation team in handling quality and regulatory questions from existing customers.
• Analyze Customers’ contracts, highlight the quality and regulatory-related contractual requirements and discuss their implementation with the relevant internal stakeholders.
• Collaborate in Vendor’s Qualification activities including vendor’s assessment questionnaire completion, audits, and provide feedback to product and operations team and
• Verify and document that internal workflows and procedures are compliant with regulatory and customers’ requirements.

Important detail:

We are operating a hybrid model where our employees choose whether to work from home or come to the office.

Requirements

The ideal candidate for this role:

• Has a genuine interest, passion, and motivation for Empatica's mission.
• Has a strong academic background, BS or MS in Biomedical Engineering
• Has at least 3 years of experience as a Quality Assurance Specialist or similar roles in a medical device, pharmaceutical company, or CRO
• Has knowledge and experience working with ISO standards (13485, 14971, ...).
• Working knowledge of applicable regulations for human subjects research (ICH-GCP, FDA regulations)
• Has excellent analytical and problem-solving skills.
• Is an autonomous person, with good organization and management skills.

Life at Empatica

You 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. You’ll 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 & Diversity

At 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 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 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
• Health Insurance
• Free healthy lunch every day
• Your personal MacBook
• Free Kindle and books
• Remote working option
• ️ Flexible working hours
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• Personal learning and development budget
• Much more…