PSelect how often (in days) to receive an alert: /ph3QA Product Quality Specialist /h3pPublished on: Jun 23, 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 /h3h3strongemWhy Join Diasorin? /em /strong /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 /h3pstrongJob Scope /strong /ppThe QA Product Quality Specialist supports the QA Product Quality Manager in all the activities related to Investigation, nonconformities (NC), CAPA and Post Market Surveillance processes and ensures that all the activities are performed according to internal procedures and in compliance with regulation requirements. /ppIn addition, through the Quality Assurance function ensures that: /pullithe industrial activities are fit for purpose, consistent and meet all internal and external requirements /lilithe Quality System is compliant with the regulatory and quality requirements /li /ulpstrongKey Duties and Responsibilities /strong /pulliSupport the correct process of NCs, CAPAs and Investigations handling and verify that it complies with the procedures /liliSupport the collection of Post-Market Surveillance (PMS) data and the management of the relevant PMS documentation /liliMonitor adherence to the defined timelines /liliEscalate to the line manager critical issues arising from NC, CAPA and Investigation management /liliSupport industrial departments coordinating the non-conformity/Out of Specification management processes /liliCollaborate with the technical teams in the definition of the correct risk assessment on the product/processes /liliVerify, approve and close NCs, CAPAs and investigations records /liliPropose, track and monitor the quality KPIs and define actions for continuous improvement /liliCollaborate during internal and external audits for the NCs, CAPAs, Investigations and PMS topics discussion /liliCollect final data from NCs, CAPA and Investigations for the preparation of annual data analysis reports /liliProvide trainings and spread the knowledge of the correct NCs-CAPAs management and Investigation and Root Cause Analysis tools /liliCollaborate with the technical teams in the definition of the correct risk assessment on the product/processes /liliSupport in evaluating the criticality of a non-conformance, defining the correct actions to be implemented and preventing recurrence of the issues /liliDraft and review standard operative procedures and to manage the Change Plans to modify them /liliSupport the departments involved in the process of approval and applying the Change Plans related to NCs, CAPAs or Investigations /liliPerform training personnel about the requirements of QMS and cGMP /liliVerify the application of the Quality Management System /liliDraft and review of standard operative procedures /liliVerify that procedures are properly established and applied to prevent non-conformity /liliSupport industrial departments in the process of requesting and applying the relevant Change /liliEvaluate the impact of the proposed Changes on its own field of competence /liliCollaborate during audits conducted by external bodies /li /ulpstrongEducation, Experience, and Qualifications /strong /pulliDegree in scientific disciplines or degree in biomedical engineering. /liliAt least two years' experience in similar or equivalent positions in chemical/pharmaceutical or medical device companies, or experience in the production/quality control of medical devices. /liliKnowledge of ISO 13485, ISO9001, FDA code, EU IVD regulation 2017/746 (IVDR). /liliUse of Office pack (Excel, PowerPoint, Word). /liliRisk management and related tools. Knowledge of investigation and Root Cause Analysis tools. /liliUse of Office pack (Excel, PowerPoint, Word). /liliRisk management and related tools. /liliStrong verbal and written communication skills. /liliSolid problem solving and analytical skills. /liliSolid interpersonal skills, including ability to negotiate and influence without authority. /liliAbility to work in a team and promote teamwork, with respect for others. /liliStrong communication and interpersonal skills with ability to work well in a high-pressure environment. /liliAbility to manage complex projects and multiple projects simultaneously. /liliAbility to achieve assigned results while respecting quality, compliance and efficiency, respecting times, deadlines and priorities. /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