Senior QA Technician at Diasorin

Diasorin 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 weve earned our reputation for excellence by developing innovative diagnostic assays and instruments that are trusted by healthcare providers around the world.Our 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.Why Join DiasorinImpactful Work: When you join Diasorin you become part of a team thats dedicated to improving lives. Your contributions will directly impact patient care making a meaningful difference in the world.Global 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.Diverse 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.Join Our Team: If youre passionate about innovation diversity and making a positive impact on healthcare Diasorin is the place for you. Were looking for passionate and talented individuals who are ready to embrace new challenges and drive healthcare solutions forward.Are you ready to be part of a dynamic team thats 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!Job ScopeThe Sr. Quality Assurance Technician is responsible for reviewing and verifying Device History Records (DHRs) to ensure compliance with internal procedures FDA regulations (21 CFR Part 820) and ISO standards (e.g. ISO 13485). This role supports the release of intermediate materials and finished medical devices and ensures product quality and regulatory compliance.Job ResponsibilitiesInspect and verify product labels and insert perform data review for material intermediate and component releases label reconciliation in DHR complete release documentation (release forms and status labels)Conduct review of documentation in accordance with released procedures GxP standards (GDP GMP) and production schedulesVerify that all required production inspection and test documentation is complete and meets release criteria including raw material status calibration etc.Attend interdepartmental meetings to support and coordinate product release such as MRB.Identify and document any discrepancies or non-conformances found during DHR review generating Non-Conformance Reports (NCs) as neededLog file maintain and archive various QA reports & recordsMaintain and track key performance metrics and assist other Quality Assurance personnel in data collection as neededPerform quality walkthroughs of manufacturing operations to drive continuous improvement and complianceAssist in continuous improvement of DHR review and related quality processesParticipate in quality investigations (e.g. CAPA NCs) related to DHR errors or product quality issues as neededProvide support during external audits and regulatory inspectionsOther duties as assignedEducation Experience and QualificationsH.S. Diploma or equivalent requiredAssociates Degree in a life science or engineering or equivalent related experience preferred3 Years Experience in FDA regulated manufacturing environment previous Quality experience preferred3 Years Experience with participating in formal audits preferredGood verbal and written communication skills in the English languageAbility to interpret a variety of instructions in written oral formComputer skills (Microsoft Windows and Office programs) familiarity with Oracle preferredWorking knowledge of GMP GDP and regulatory requirements (FDA ISO 13485)Ability to apply sampling techniquesAbility to manage and present data as it relates to product releaseHighly organized with proven time management and prioritization skillsAbility to maintain attention to detail in a fast-paced environmentComfortable with routine work but able to switch back and forth between tasksStandard Physical DemandsVision (Color) on the job is required - OccasionallyStandard Working ConditionsMust work onsite at Luminex office - ConstantlyWork is normally performed in an office and a manufacturing environment - ConstantlyPossible exposure to biological or chemical hazard extensive noise and/or working with lasers - OccasionallyFrequent use of personal computer copiers printers and telephones - FrequentlyFrequent standing walking sitting listening writing typing and talking - FrequentlyFrequent work under deadlines and in direct contact with others - FrequentlyOccasional lifting of 30 lbs. and climbing - OccasionallyTravel Requirements10% Domestic travel may be requiredDiasorin 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.In 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.Diasorin 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- to request an accommodation.The 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.Diasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations.Please 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.This position is not eligible for partnership with a third-party search firm vendor without expressed written consent from the Diasorin Human Resources Department.Required Experience:Senior IC Key Skills Continuous Integration,Quality Assurance,FDA Regulations,Root cause Analysis,TFS,Food Processing,ICH Q10,Jira,Software Testing,Quality Management,Selenium,Github Employment Type : Full-Time Experience: years Vacancy: 1