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.
Responsibilities
The QAS will directly be involved in the following activities:
- Prepare, verify and update QMS documentation;
- Observe the work environment and verify the requirements are met;
- Collaborate to the management of supplier audit and quality agreements;
- Collaborate to the management of internal audit;
- Collaborate to the management of the relationship with external certification authorities;
- Collaborate to the educational activities of Tensive’s personnel related to tool of Quality;
- 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;
- Support the Clinical Study Management Team in clinical evaluation process;
- Propose corrective action plans in collaboration with CEO, CQA&RAO and CTO;
- 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