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Quality Assurance Specialist (Closed)

Location: Milan, Italy

The Opportunity

Tensive is a biomedical company that is developing an innovative scaffold aiming to improve breast cancer patients’ quality of life, by offering a natural breast reconstruction.

We are looking for a Quality Assurance Specialist (QAS) to work closely with our Quality Assurance & Regulatory Affairs (QA&RA) team in executing and improving our Quality Management System (QMS) in accordance with the requirements of ISO 13485:2016. The successful candidate will also be responsible for continually monitoring its relevance and applicability over time.

We love to hire collaborative and self-motivated people with a passion for learning and a teamwork spirit. Our team invests heavily in coaching new hires.


The QAS will directly be involved in the following activities:

  1. Prepare, verify and update QMS documentation;
  2. Observe the work environment and verify the requirements are met;
  3. Collaborate to the management of supplier audit and quality agreements;
  4. Collaborate to the management of internal audit;
  5. Collaborate to the management of the relationship with external certification authorities;
  6. Collaborate to the educational activities of Tensive’s personnel related to tool of Quality;
  7. Observe the production process and coordinate validation of the manufacturing steps, including software applied, with the goal to minimize errors and products’ defects or non-conformities;
  8. Support the Clinical Study Management Team in clinical evaluation process;
  9. Propose corrective action plans in collaboration with CEO, CQA&RAO and CTO;
  10. Support risk management activities.

The successful candidate will work closely with the other members of the QA&RA team to ensure that all of the abovementioned activities are completed according to Tensive’s implementation timeline.

Minimum Qualifications:

  • BSc, preferably in law, medicine, pharmacy, engineering or another relevant scientific discipline
  • 1-3 years of relevant work experience within the area of Quality Assurance
  • 1-3 years of work experience in multidisciplinary teams

Soft Skills: 

  • Excellent interpersonal skills with the ability to interact and communicate effectively
  • Ability to independently organize his/her own schedule to achieve goals and meet projects and company deadlines
  • Excellent attitude to teamwork and ability to work in a small, fast-growing startup environment
  • Proficiency in written and spoken English is highly preferred
  • Excellent knowledge of the Microsoft Office package
  • Ability to manage stress during intense working periods
  • Problem solving and critical thinking skills

Preferred Requirements:

  • Relevant work/study experience abroad
  • Relevant work experience with an ISO certification body
  • Experience in medical device companies is preferred
  • Experience in clinical evaluation of a medical device is preferred
  • Knowledge of and experience in QMSs (preferably within the medical device sector)

Please send your CV to careers@tensivemed.com