Quality Assurance Specialist (Closed)

Tensive; Monza; In loco; EUR 35.000 - 50.000; Tempo pieno

Descrizione del lavoro

A biomedical company is seeking a Quality Assurance Specialist to enhance its Quality Management System in compliance with ISO 13485:2016 standards. The candidate will manage audits and documentation while supporting clinical evaluations. An ideal applicant will have a BSc in a relevant field and 1-3 years of Quality Assurance experience. Join a collaborative team in a fast-growing startup environment.

Competenze

• 1-3 years of relevant experience in Quality Assurance.
• Experience working in multidisciplinary teams.
• Proficiency in written and spoken English.

Mansioni

• Prepare, verify, and update QMS documentation.
• Manage supplier audits and quality agreements.
• Oversee internal audits.
• Monitor production processes to minimize errors.
• Support clinical evaluations with the Clinical Study Management Team.

Conoscenze

Interpersonal skills

Communication skills

Teamwork attitude

Problem-solving skills

Adaptability

Critical thinking skills

Formazione

BSc in law, medicine, pharmacy, engineering, or related scientific field

Strumenti

Microsoft Office

Descrizione del lavoro

Tensive is a biomedical company developing an innovative scaffold to improve breast cancer patients’ quality of life through natural breast reconstruction.

We are seeking a Quality Assurance Specialist (QAS) to collaborate closely with our Quality Assurance & Regulatory Affairs (QA&RA) team. The role involves executing and enhancing our Quality Management System (QMS) in line with ISO 13485:2016 standards. The successful candidate will also monitor the system's ongoing relevance and applicability.

We value collaborative, self-motivated individuals passionate about learning and teamwork. Our team invests heavily in coaching new hires.

Responsibilities

• Prepare, verify, and update QMS documentation
• Observe the work environment to ensure requirements are met
• Manage supplier audits and quality agreements
• Oversee internal audits
• Coordinate with external certification authorities
• Contribute to educational activities related to quality for Tensive’s personnel
• Monitor production processes and validate manufacturing steps, including software, to minimize errors and non-conformities
• Support the Clinical Study Management Team in clinical evaluations
• Propose corrective actions in collaboration with leadership

The QAS will work closely with the QA&RA team to ensure timely completion of these activities.

Minimum Qualifications

• BSc in law, medicine, pharmacy, engineering, or related scientific field
• 1-3 years of relevant experience in Quality Assurance
• Experience working in multidisciplinary teams

Soft Skills

• Excellent interpersonal and communication skills
• Ability to independently organize work and meet deadlines
• Strong teamwork attitude, adaptable to a fast-growing startup environment
• Proficiency in written and spoken English
• Excellent knowledge of Microsoft Office
• Ability to manage stress effectively
• Problem-solving and critical thinking skills

Preferred Requirements

• Experience abroad in relevant roles or studies
• Experience with ISO certification bodies
• Background in medical device companies
• Experience in clinical evaluation of medical devices
• Knowledge of and experience with QMS, especially in the medical device sector

Interested candidates are encouraged to send their CV to J-18808-Ljbffr.