Qa&Ra Specialist San Lazzaro di Savena

Qa&Ra Specialist
San Lazzaro di Savena
Emilia Romagna, San Lazzaro di Savena

Reporting directly to the QA&RA Manager, ensure regulatory compliance of products with the applicable standards and regulations and ensure Quality Management System compliance with applicable regulatory requirements, ISO 13485 standard and CFR Title 21 part 820.

KEY RESPONSABILITIES:

- Maintain accurate and up-to-date documentation related to quality and regulatory activities.

- Keep the organization informed about changes in regulations and best practices.

- Develop and deliver training programs on quality and regulatory requirements.

- Perform root cause analysis and implement corrective and preventive actions.

- Manage the investigation and resolution of customer complaints.

- Collaborate in risk management processes.

- Contribute to the preparation of post-market surveillance reports and trend analyses.

- Participate in design & development activities, including design reviews.

- Qualify and monitor suppliers based on their quality and regulatory capabilities.

- Participate in internal, supplier and third-party audits.

- Prepare and submit regulatory documentation for product approvals and certifications.

- Interface with regulatory agencies to address inquiries and facilitate product registrations.

- Ensure compliance of products with regulatory requirements.

QUALIFICATIONS & SKILLS

- Degree in technical/scientific field, preferably Biomedical Engineering.

- Knowledge of QA&RA requirements for medical devices is a plus.

- Excellent written and spoken English.

Knowledge of other languages is a plus.

- Excellent communication and collaboration skills.

- Proactive approach and ability to work independently

- Strong analytical and problem-solving skills.

- Valid driver's license.

ATTRIBUTES

- Strong commitment and proactive initiative

- Customer-oriented

Contratto di lavoro: Tempo pieno, Tempo indeterminato, Tempo determinato, Apprendistato

Benefit:

- Computer aziendale

- Convenzioni aziendali

- Supporto allo sviluppo professionale

Disponibilità:

- Dal lunedì al venerdì

Retribuzione supplementare:

- Premio di produzione

- Tredicesima

Istruzione:

- Laurea magistrale (o specialistica) (Obbligatorio)

Esperienza:

- Quality Assurance & Regulatory Affairs Specialist: 4 anni (Obbligatorio)

Lingua:

- Italiano (Obbligatorio)

- Inglese (Obbligatorio)

Sede di lavoro: Di persona