PSelect how often (in days) to receive an alert: /ph3QA Post Market Manager /h3pPublished on: Jun 27, 2025 /ppJob Category: Quality /ppEmployment type: Regular Full Time /ph3emDiasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. With a legacy spanning over 50 years, we've earned our reputation for excellence by developing innovative diagnostic assays and instruments that are trusted by healthcare providers around the world. /em /h3h3emOur broad offering of diagnostic tests and Licensed Technology solutions, made available thanks to ongoing investments in research, positions us as the player with the widest range of specialty solutions in the sector and identifies us as the "Diagnostics Specialist." /em /h3h3bemWhy Join Diasorin? /em /b /h3h3emImpactful Work: When you join Diasorin, you become part of a team that's dedicated to improving lives. Your contributions will directly impact patient care, making a meaningful difference in the world. /em /h3h3emGlobal Reach Innovation: Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world, expanding your horizons, and contributing to global healthcare solutions at the forefront of the diagnostic industry. /em /h3h3emDiverse and Inclusive Culture: We believe in the strength of diversity, and our inclusive culture reflects this commitment. We value your unique perspective and offer a supportive, collaborative environment where everyone can thrive. /em /h3h3emJoin Our Team: If you're passionate about innovation, diversity, and making a positive impact on healthcare, Diasorin is the place for you. We're looking for passionate and talented individuals who are ready to embrace new challenges and drive healthcare solutions forward. /em /h3h3emAre you ready to be part of a dynamic team that's shaping the future of diagnostics? Join Diasorin and become a catalyst for change in the world of healthcare. Apply today and be a part of our exciting journey toward a healthier, more connected world. Together, we can make an impact! /em /h3pbJob Scope /b /ppThe QA Post Market Manager is responsible to: /pulliOversee all activities related to the complaint handling process from QA standpoint /liliManage the post market surveillance activities to ensure that medical devices continue tobe safe and well-performing and to ensure corrective actions are undertaken when necessary /liliCollect and evaluateexperience gained from medical devices that have been placed on the market and to identify the needto take any action or to highlight opportunities to improve. /li /ulpbKey Duties and Responsibilities /b /pulliManaging the Post-Market Surveillance process and related deliverables to ensure compliance with all applicable internal and external requirements /liliEnsuring timely and accurate processing for PMS data collection, plans and periodic reporting /liliOrganizing PMS team, to plan and gather all the information needed for the creation of PMS reports and Plans /liliOverseeing the generation of Post-Market Surveillance plans during the product development. /liliMaintaining up-to-date knowledge on global regulatory requirements for PMS, vigilance and reporting /liliEnsuring the communication of PMS result to product SME, PD, production, customer care and Top Management /liliRepresenting the PMS activities as a subject matter expert in support of internal and external audits /liliOverseeing Complaint processing in compliance with FDA, Health Canada, EU, China and other country specific vigilance regulations /liliManaging Field Corrective Action Activities and Adverse Event reporting to ensure compliance /liliProvides and verifies the application of the Quality Management System ensuring the adequacy and updating of Quality System with respect to the regulatory and quality requirements /liliConsistently striving to improve quality according to the highest standards /liliCooperating with other function to ensure that the process and procedures are in compliance with quality standard (ISO and GMP) /liliproviding training and spread the knowledge of the Quality System at all company Ievels /liliPerforming internal and external audit /liliCollaborating with technical groups to identify product improvement opportunities /liliCollaborating in the definition of the correct risk assessment on the product/process. /li /ulpbEducation, Experience, and Qualifications /b /pulliDegree in scientific disciplines /liliKnowledge of regulatory / compliance requirements applicable to in vitro diagnostics / medical devices /liliAt least five years of Medical Device / -IVD or chemical-pharmaceutical industry experience in similar position /liliUse of Office pack /liliProject Management /liliRisk management and related tools /liliWorking knowledge of FDA Medical Device Regulations including Quality System Regulation 21 CFR Part 820, provides and verifies that the Quality Management System meets the requirements of lSO900l, 1S013485, US FDA QS Regulation (21CFR820) and the Medical Device Regulation (SOR I 98-282) of Canada /liliStrong analytical skills including trend and statistical analysis Project Management. /liliStrong verbal and written communication skills /liliSolid problem solving and analytical skills /liliMarked ability to identify risks associated with a product/process issue /liliSolid interpersonal skills, including ability to negotiate and influence without authority /liliAbility to supervise team members or to work as part of a team /liliAbility to manage complex projects and multiple projects (5+) simultaneously /liliStrong communication and interpersonal skills with ability to work well in a high-pressure environment /liliStrong competency in Customer Focus and Driving for Results /liliFluent knowledge of the English language /li /ulh3emDiasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability. /em /h3h3emIn compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and Canada and to complete the required employment eligibility verification document form upon hire. /em /h3h3emDiasorin is committed to providing reasonable accommodations for qualified individuals with disabilities. If you are a US or Canada candidate and require assistance or accommodation during the application process, please contact the North America Talent Acquisition Team at or 1-800-328-1482 to request an accommodation. /em /h3h3emThe above job description is intended to describe the general content, identify the essential functions, and set forth the requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. /em /h3h3emDiasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations. /em /h3h3emPlease note that offers of employment at Diasorin may be contingent upon successful completion of a pre-employment background check and drug screen, subject to applicable laws and regulations. /em /h3h3emThis position is not eligible for partnership with a third-party search firm vendor without expressed, written consent from the Diasorin Human Resources Department. /em /h3 #J-18808-Ljbffr