Amanda Kaminski Email and Phone Number

Developed, implemented and managed appropriate quality systems and practicesEnsured a high level of compliance to FDA QSR/cGMPs and ISO 13485 in all assigned areasConducted internal audits in accordance with established guidelinesCoordinated training in GMPs and Quality System awarenessLead CAPA Board and coordinated CAPA activitiesMentored Nonconformance and CAPA OwnersManaged >80 plus CAPAs across three sitesEnsured compliance with company quality assurance policies and practicesMaintained CAPA files and provided metrics on company performance to Quality objectivesManaged audit readiness activitiesKey participant in audits performed by regulatory bodies (FDA, Notified Body) and Corporate Compliance groupCoordinated Management Reviews and data preparationPerformed responsibilities required by the Quality System and other duties as assigned or requested

Responsible for developing, implementing and managing appropriate quality systems and practices to ensure that the Stryker Neurovascular Site is compliant to the Stryker Neurovascular Quality Manual and all relevant regulatory and notified body requirements. Responsibilities include the following:Ensuring a high level of compliance to FDA QSR/cGMPs and ISO 13485 in all assigned areas.Demonstrating a primary commitment to patient safety, product quality and compliance with the Stryker Neurovascular Quality Manual and its governing regulations.Ensuring internal and selected supplier compliance audits are conducted in accordance with established guidelinesCoordinating training in GMPs and Quality System awarenessDeveloping and continuously improves Quality Systems at the site level to comply with corporate requirements and site needsLeading CAPA Board and coordinate CAPA activities.Ensuring compliance with company quality assurance policies and practices.Maintaining the CAPA and Internal Audit schedules and files and provides metrics on company performance to Quality objectives.Key participant in audits performed by regulatory bodies (FDA, Notified Body) and Corporate Compliance group.Communicating with regulatory agencies, at the direction of Management Representative, on selected regulatory compliance issues and regulatory agency audits and inspections.Coordinating Management Reviews and data preparationPerforming responsibilities required by the Quality System and other duties as assigned or requested

In this position I support post market surveillance activities, specifically those governing global complaint handling processes. This involves participating in and leading small and large scope projects that span multiple functions and sites; owning, writing, reviewing, analyzing, and revising Standard Operating Procedures (SOP); assisting with and performing Corrective Action/Preventive Action (CAPA) root cause investigations; and serving as a Subject Matter Expert (SME) for complaint and medical device reporting processes during internal audits and external inspections.Experience:-Integrated complaint handling and medical device reporting processes of acquired companies-Served as SME for internal audits and external inspections-Participated in and led small and large scope projects that involved multiple departments and sites-Managed department document change control processes-Trained over 60 manufacturing sites and service centers on complaint investigation requirements-Provided on-site training as needed to complaint handling units in the continental U.S.-Owned CAPA records-Performed impact assessments for change control management purposes

In this position I serve as a subject matter expert for the complaint handling process governed by 21 CFR 820.198. I am involved in document creation and change control. In addition, I am responsible for coordinating employee training, administering employee training, assisting in the maintenance of employee training plans, monitoring upcoming training to ensure on-time completion, updating training curriculum, as well as participating in small scope projects.Experience:-Wrote Standard Operating Procedures (SOP)-Created Global Job Aids on how to document complaint investigation activities-Owned and investigated process related Corrective and Preventative Actions (CAPA)-Participated in Document Change Review and CAPA Change Review Boards-Managed updates to departmental documents-Coordinated and administered training-Served as the touch point for the departments incoming employees and contractors -Facilitated maintenance of departmental training plans-Updated training curriculum-Assisted in the assessment of departmental compliance-Maintained knowledge of FDA Quality System, Medical Device Reporting Regulations, and Current Good Manufacturing Practices for Finished Pharmaceuticals (21 CFR 820, 803, 314, and 211)-Managed workflows for complaints and CAPA-Prioritized multiple projects to ensure compliance with regulations and standard operating procedures- Worked with cross-functional teams on continuous improvement activities and projects-Served as a Subject Matter Expert during internal and external audits-Utilized Microsoft Office, Trackwise, J.D. Edwards, Siebel, TeamCenter, and Post Market Data Analysis systems-Employed critical thinking, analytical thinking, problem solving, communication, and organizational skills

In this position I was responsible for managing a workflow of high-risk and in-depth complaints, which included responding to customers, collecting additional information, and coordinating investigation tasks such as batch reviews, service history reviews, device history reviews, event history log reviews, and sample evaluations. I also prepared and submitted product malfunction and adverse event MDRs for submission to the FDA.Experience:-Processed low-risk, high-risk, and in-depth drug and medical device complaint investigations-Communicated with customers-Prepared and submitted Medical Device Reports (MDR) to FDA-Wrote Standard Operating Procedures (SOP)-Owned and investigated process related Corrective and Preventative Actions (CAPA)-Participated in Document Change Review and CAPA Change Review Boards-Coordinated and administered training-Served as the touch point for the departments incoming employees and contractors -Facilitated maintenance of departmental training plans-Updated training curriculum-Assisted in the assessment of departmental compliance-Maintained knowledge of FDA Quality System, Medical Device Reporting Regulations, and Current Good Manufacturing Practices for Finished Pharmaceuticals (21 CFR 803, 820, and 211)-Managed workflows for complaints and CAPAs-Prioritized multiple projects to ensure compliance with regulations and standard operating procedures- Worked with cross-functional teams on continuous improvement activities and projects-Served as a Subject Matter Expert during internal and external audits-Utilized Microsoft Office, Trackwise, J.D. Edwards, Siebel, TeamCenter, and Post Market Data Analysis systems-Employed critical thinking, analytical thinking, problem solving, communication, and organizational skills

-Processed low-risk, and in-depth drug and medical device complaint investigations-Communicated with customers-Prepared and submitted Medical Device Reports (MDR) to FDA-Maintained knowledge of FDA Quality System, Medical Device Reporting Regulations, and Current Good Manufacturing Practices for Finished Pharmaceuticals (21 CFR 803, 820, and 211)- Worked with cross-functional teams on continuous improvement activities and projects-Utilized Microsoft Office, Trackwise, J.D. Edwards, Siebel, TeamCenter, and Post Market Data Analysis systems-Employed critical thinking, analytical thinking, problem solving, communication, and organizational skills