Alyssa Kay Easton Email & Phone Number

Boston, Massachusetts, Us

* Implementation and maintainance of Global procedures/ processes associated with complaint management, complaint investigations, regulatory reporting (US MDR, EU MDR, EU defective Product reporting), product security investigations, and monthly/quarterly complaint trending* Providing daily guidance and direction to the complaints team related to the processing and resolution of incoming product complaints* Ensuring timely closure of quality records in compliance with established procedures* Leading periodic reviews of Quality System KPIs and other metrics to identify opportunities for improvement, and mitigate compliance risks* Preparing the Quality Management Review data review metrics* Trending and Data analytics for the Monthly Global Product Complaint Trend Report* Quality partner for complaint and investigation requirements of Alexion clinical trials

Wayne, Pa, Us

o Support implementation of the Enterprise Excellence strategy to the global Quality Assurance and Regulatory Affairs organization. o Support the organization through advancement of a high-performance Lean culture using Lean principles and practices to identify and prioritize continuous improvement efforts. o Partnership with global stakeholders to drive quality culture, communication, and training efforts across the enterprise. o Lead global teams in tasks such as project management, kaizen events, value stream mapping, training, communication and implementation responsibilities.

Wayne, Pa, Us

o Subject matter expert in risk management procedures, work instructions and tools compliant with ISO 14971:2019.o Ownership of global product risk management procedures and guidance documents. o Develop and implement Global Quality Plan for global roll out of new risk management process.o Provide risk management training and mentorship to sustaining and new project teams across all business units. o Assist in analysis of product complaints, medical device reporting (MDR), and other post-market surveillance data.o Expansion of post market risk management processes, mapping of complaint data to risk files, risk-based trending and develop and implement global trainingo Support product teams in identifying and implementing risk mitigations, assistance with completion of risk analysis to ensure product line compliance to ISO 14971:2019.

Deerfield, Illinois, Us

• Development of Product Risk Management deliverables for new product design in sensors and monitoringo Failure Mode and Effects Analysis (FMEA)o Risk Assessment and Control Tables (RACT)o Risk Acceptability Assessmento Risk-based post market complaint trending• Experience with IEC 60601, ISO 14971:2019, ISO 13485, 21 CFR 820, IEC 60812, IEC 61025• Drive requirements management planning activities and labeling requirements content

Deerfield, Illinois, Us

• Ownership of Product Risk Management for market products in Infusion Systemso dFMEA, pFMEA, uFMEA o Risk Assessment and Control Tables (RACT)o Risk Acceptability Assessmento Risk-based post market complaint trendingo Risk evaluations for product changes, nonconformances, post market investigations and process improvements• Experience with IEC 60601, BS EN ISO 14971:2012, ISO 13485, 21 CFR 820, IEC 60812, IEC 61025• Subject Matter Expert for investigations during internal and external audits• Work on global cross-functional teams providing risk management expertise on product changes• Work on global cross-functional teams to improve corporate risk management procedures and guidance documents

Deerfield, Illinois, Us

• Review of complaints and service data to determine risk level and escalate if needed• Completion of engineering investigations and reports• Complete root cause analysis device investigations to drive corrective action and product improvements • Review of complaint and Medical Device Report (MDR) data to identify trends and systemic issues• Complete investigations to drive process improvements• Subject Matter Expert for investigations during internal and external audits• Scribe during internal and external audits• Assisted in drafting procedures and guidance documents• Assisted in building tools to help team manage workload and improve record quality• Creation of visual management aid to review with senior management

Deerfield, Illinois, Us

• Aligning Quality Management System to meet all local and federal requirements.• Evaluation and investigation of complaints to determine FDA reportability• Drafting and timely submission of MDRs to the FDA.• Obtaining critical clinical and engineering event details to ratify that internal documentation is complete and accurate, meeting 21 CFR Part 803.• Edited and published Standard Operating Procedures, Quality Work Instructions, and other guidance documentation to align with Global procedures• Assisted in implementation of Peer Review system to improve record quality• Assist in building tools to help team manage workload and improve record quality• Responsible for new hire training

Deerfield, Illinois, Us

Handling of post market customer complaints for infusion pumps. Evaluating and Investigating complaints to determine FDA reportablity through communication with customers, engineers and evaluators. Drafting and submission of Medical Device Reports (MDR) to FDA.

Bachelor Of Science (Bs), Biomedical Engineering

Molecular Biology And Genetics