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;
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
#J-18808-Ljbffr