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Design Control Review Specialist

3 mesi fa

Parma, Emilia-Romagna, Italia Amaris Consulting A tempo pieno
**Who are we? **:**Amaris Consulting** is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade - this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We're focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.

**Brief Call**: Our process typically begins with a brief virtual/phone conversation to get to know you The objective? Learn about you, understand your motivations, and make sure we have the right job for you
**Interviews** (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities
**Case study**: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.

We look forward to meeting you
**Job description**:
**DESIGN CONTROL REVIEW SPECIALIST - PHARMA INDUSTRY**

**Cosa farai?**
- Collaborare con i clienti e i dipartimenti interni per chiarire i requisiti del progetto.
- Ti occuperai della revisione e preparazione di documnetazione di Design Control per prodotti drug-device.
- Gestirai la revisione di test report.
- Partecipare attivamente alle attività del progetto, dimostrando un approccio proattivo e iniziativa.

**Requisiti**:

- Esperienza comprovata di 3-4 anni nella mansione, o in mansioni analoghe.
- Conoscenza approfondita della ISO 13485 e disposizioni MDR.
- Esperienza strutturata in ambito Medical Device e nel controllo della documentazione correlata.
- Laurea in Ingegneria Biomedicale (o disciplina equivalente, ad esempio CTF, Chimica etc)
- Conoscenza avanzata della lingua inglese (almeno C1)
- Forte attitudine alla risoluzione dei problemi

** Che cosa offriamo?**
- Lavoro per obiettivi con monitoraggio trimestrale.
- Percorso di crescita formativo e tecnico.
- Clima di lavoro inclusivo.
- Lunch vouchers di 8 € per giornata lavorativa.
- Accesso gratuito alla piattaforma Mantu Academy con più di 500 corsi.
- Accesso gratuito alla piattaforma Udemy con più di corsi.
- Consulenza psicologica.
- **Pioneer Spirit**: voglia di esplorare le nuove tecnologie, idee e competenze per costruire un mondo più sostenibile.
- **Care**: impegno nella promozione della diversità, della meritocrazia e della salvaguardia dell'ambiente per un futuro migliore.
- **Performance**:costante ambizione di raggiungere l'eccellenza attraverso la creatività, l'innovazione e la tecnologia.
- **Trust**: la fiducia è un pilastro del progresso, che spinge alla libertà, alla creatività e all'innovazione.
- **Independence**: l'indipendenza è la base per realizzare un futuro prospero e agile.