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