22 ott - Milano
Empatica
As a Quality Assurance Specialist at Empatica, you will be a key member of the Quality and Regulatory Department, supporting the maintenance of the Quality Management System as well as:
Champion Quality culture and compliance within the different development teams, supporting them in the compliance effort
Continually seeks to drive improvements in product and process quality.
Provides the quality/independent review at defined design reviews, design plans, risk management, design verification/validation protocols and reports, for new development projects as well as design/process changes to existing products.
Support Engineering manager with the activities related to change management and new product development. Support developers in creating design control documentation, making sure product requirements and regulatory requirements are aligned.
Support Design transfer activities to ensure quality compliance of the manufacturing process.
Interfaces with Regulatory Affairs, Clinical Science, Marketing, and product manager to translate their needs in actionable and regulatory compliant requirements.
Support Regulatory affairs in drafting EU Technical Documentation and US 510(k)s and De Novo submissions
Keeps up to date on all ISO/EN/FDA/MDR and other Product Development related regulatory requirements and relay this information to the Product Development group.
Has at least 3 years of experience as a Quality Assurance Specialist, Design Quality Engineer, Quality Engineer or similar roles in a company that designs/manufactures medical devices.
Has knowledge and experience working with ISO standards (13485, 14971, ...).
Has knowledge and experience working with IEC standards (60601, 62304, ...).
Is an autonomous person, with good organization and management skills.
Is a native English speaker or have worked in English for the past at least 3 years.
Empatica operates in an international environment with presence in Europe, the US, and Korea. All work is conducted in English.
We are operating a hybrid model where our employees choose whether to work from home or come to the office, however, please note that this position is not fully remote and in-person presence at the office is necessary.
You will join a fast-growing, international, and diverse team of 120+ 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 who 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.
We have colleagues from 30 different countries, while over 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
37,000–45,000 gross per year, commensurate with the candidate’s experience and background
Employee stock options - we want everyone who joins us to own part of the company and our success
Wellhub 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
Free Kindle and books
- Flexible working hours
- Always double-check the emails you receive. Make sure all communications come from official Empatica email addresses ending in @empatica.
23 ott - Milano
ALI
23 ott - Venezia
ADECCO
23 ott - Torino
Jobgether
23 ott - Novellara
Loa Marketing