*_what quality assurance _*complaints specialist *_contributes to cardinal health_*_responsibilities_*responds to significant quality issues and in support of the manager, conducts root cause analyses, reports on relevant quality metrics and trends, and develops insights for internal stakeholders.- responsible for complaint investigations, research, analysis and reporting to resolve quality complaints.- gather data, investigate, analyze, and evaluate other information alongside it to identify possible problem areas.review analysis to write up reports with recommendations, including preventive or corrective actions.- ensures fulfillment of external reporting requirements related to area of specialty, such as submitting necessary materials for product recalls.submits reports for internal review prior to submission to regulatory bodies.- provides guidance to internal stakeholders regarding adherence to internal quality assurance policies and procedures as well as external requirements.- collaborates with quality assurance specialists in other specialty areas as necessary to develop recommendations.- supports the change control program, for new process development and change.- updates standard operating procedures in response to product changes and regulatory developments under the general guidance of the manager.resolutions to significant quality issues, such as recalls or customer complaints, may set precedent for updates to sops.- supports regulatory queries, from the complaints perspective, to support canada and usa post market surveillance teams regulatory submissions.- supports the manager, quality assurance in quality audits and inspections (internal and external).- provides guidance to junior level specialists on complex issues, assists with onboarding trainings, and frequently reviews the work of junior level specialists prior to delivery to a manager.*_qualifications (minimum requirements)_*- 2-4 years of quality experience in highly regulated manufacturing environment- bachelor's degree in life sciences, biology or related field.- english: advance (read, write, speak).- excel: advance level of experience- ability to sit for prolong periods of time.*_ preferred and good to have_*- engineering degree- knowledge of iso *- medical device manufacturing experience*_what is expected of you and others at this level_*- works on projects of moderate scope and complexity- identifies possible solutions to a variety of technical problems and takes action to resolve- applies judgment within defined parameters- receives general guidance and may receive more detailed instruction on new projects- work reviewed for sound reasoning and accuracy""- cardinal health supports an inclusive workplace that values diversity of thought, experience and background.we celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day.cardinal health is an equal opportunity/affirmative action employer.all qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law._*_what quality assurance _*complaints specialist *_contributes to cardinal health_*_responsibilities_*responds to significant quality issues and in support of the manager, conducts root cause analyses, reports on relevant quality metrics and trends, and develops insights for internal stakeholders.- responsible for complaint investigations, research, analysis and reporting to resolve quality complaints.- gather data, investigate, analyze, and evaluate other information alongside it to identify possible problem areas.review analysis to write up reports with recommendations, including preventive or corrective actions.- ensures fulfillment of external reporting requirements related to area of specialty, such as submitting necessary materials for product recalls.submits reports for internal review prior to submission to regulatory bodies.- provides guidance to internal stakeholders regarding adherence to internal quality assurance policies and procedures as well as external requirements.- collaborates with quality assurance specialists in other specialty areas as necessary to develop recommendations.- supports the change control program, for new process development and change.- updates standard operating procedures in response to product changes and regulatory developments under the general guidance of the manager.resolutions to significant quality issues, such as recalls or customer complaints, may set precedent for updates to sops.- supports regulatory queries, from the complaints perspective,