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.ResponsibilitiesThe 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 discipline1-3 years of relevant work experience within the area of Quality Assurance1-3 years of work experience in multidisciplinary teamsSoft Skills:Excellent interpersonal skills with the ability to interact and communicate effectivelyAbility to independently organize his/her own schedule to achieve goals and meet projects and company deadlinesExcellent attitude to teamwork and ability to work in a small, fast-growing startup environmentProficiency in written and spoken English is highly preferredExcellent knowledge of the Microsoft Office packageAbility to manage stress during intense working periodsProblem solving and critical thinking skillsPreferred Requirements:Relevant work/study experience abroadRelevant work experience with an ISO certification bodyExperience in medical device companies is preferredExperience in clinical evaluation of a medical device is preferredKnowledge of and experience in QMSs (preferably within the medical device sector)Please send your CV to ******#J-18808-Ljbffr
