Quality Assurance Specialist

Empatica; Lombardia; Híbrido; EUR 37.000 - 45.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health Insurance

Employee stock options

Offices in Milan and Boston

Flexible working hours

Wellhub gym access

Descripción de la vacante

Empatica is seeking a Quality Assurance Specialist to join the Quality and Regulatory Department. The role supports maintaining the Quality Management System and ensures design control, risk management, and regulatory compliance across development projects.

The ideal candidate has a Biomedical Engineering background with at least 3 years in QA for medical devices, knowledge of ISO 13485/14971, IEC 60601/62304, MDR 2017/745, and strong English proficiency.

Formación

• BS or MS in Biomedical Engineering.
• At least 3 years of QA/Design QA experience in medical devices.
• Knowledge of ISO 13485 and 14971.
• Knowledge of IEC 60601 and 62304.
• Knowledge of MDR 2017/745.
• Excellent analytical and problem-solving skills.
• Autonomous with good organization and management.
• Native English speaker or English work experience for at least 3 years.

Responsabilidades

• Champion Quality culture and ensure compliance across development teams.
• Drive improvements in product and process quality.
• Provide quality reviews at design reviews, risk management, V&V, and related reports.
• Support risk management activities.
• Assist change management and new product development documentation.
• Support design transfer to ensure quality of manufacturing.
• Translate stakeholder needs into regulatory compliant requirements.
• Maintain and update design control procedures to meet regulatory standards.
• Assist Regulatory affairs with EU/US submissions.

Conocimientos

Biomedical Engineering

Quality Assurance

Analytical skills

Autonomous

English proficiency

Educación

BS or MS in Biomedical Engineering

Descripción del empleo

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 team in performing required Risk Management activities
• 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.
• Implement, maintain and update procedures that ensure that the design control process constantly meets Empatica’s and regulatory requirements.
• Support Regulatory affairs in drafting EU Technical Documentation and US 510(k)s and De Novo submissions
• Ensure production activities are compliant with internal procedures and internationally applicable standards.
• 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.

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, 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, ...).
• Has knowledge of MDR 2017/745.
• Has excellent analytical and problem-solving skills.
• 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.

Some important details:

• 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.

Life at Empatica

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.

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 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.

• Salary range: €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
• We have offices in Milan City Center and Downtown Boston
• Health Insurance
• 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
• Personal learning and development budget
• Much more…