Michelle Madar

KEY SKILLS AND AREAS OF EXPERTIES

Quality Management Systems Expert with years of experience and broad background in Quality Assurance (QA), Quality Systems (QS), Complaint Management, Post Market Surveillance, Supplier Quality Management, Internal and External Audits, SCARs and CAPA management; Working knowledge of international standards and FDA’s Quality System Regulation/Current Good Manufacturing Practices, 21CFR Parts 820, 803, 806, ISO13485, ISO 9001, ISO14791, and EUMDR. EDUCATION AND ADDITIONAL SKILLS

UOT -BS in Metallurgical Engineering

Proficient in: Salesforce, Trackwise, Veeva, Agile, Brio, MS Project, Oracle, Outlook, Excel, Visio, SharePoint, PowerPoint, SAP, Solid Works, QCBD, MS Teams, QAD and CatsWeb

ad0ugu@r.postjobfree.com 408-***-**** IRVINE, CA 92618 PROFESSIOANL EXPERIENCE

Sr. Quality Management Systems Specialist – M & S Consulting 2021-Present

• Provides insights and recommendations based on data analysis to support decision-making and continuous improvement efforts.

• Analyzing key metrics for trends indicating the effectiveness of the QMS, making recommendations regarding system improvements, and facilitating the training required to implement the improvements.

• Managing QA activities such as reviewing, approving, and managing change controls, deviations, SOPs, and corrective actions as needed.

• Creation, review, and improvements of Quality Systems to meet standards and regulations regarding: ISO 13485/9001; European Directives for Medical Devices (CE Mark), US-FDA QSR.

• Provides support for internal and external audits with regulatory bodies (i.e., FDA, TUV).

• Overseeing and coordinating the investigation of Customer Complaints and Non-conformities.

• Evaluation of Complaint Handling System and records. Review complaints for potentially reportable AE status, including evaluation and follow-up regarding MDR reporting.

• Creating and revising SOPs associated with shared Quality Systems.

• Review, assessment, and recommendations for resolution of CAPA and Complaint Management systems. Complaint and Post Market Surveillance Manager - Breathe Technologies 2019-2020

• Process owner for complaint handling and vigilance reporting.

• Assessed complaint information provided, gathered any missing information for complainant file, and escalated complaint to appropriate parties as needed, ensuring timely processing of complaints.

• Provided supervision and direction to the Complaint Handling Team including staffing, training, planning, assigning, and directing workflow and goal setting.

• Processed, investigated, documented, and monitored trending and reporting of product defect complaints assigned in accordance with company guidelines and external regulatory requirements for the handling of customer complaints.

• Completed and submitted MedWatch forms to the FDA and other vigilance reports to international health authorities.

• Responsible for generating data reports from the complaint handling database (Trackwise and Salesforce).

• Coordinated with internal departments (Customer Service, Regulatory Affairs, Quality Assurance, Medical Affairs, Manufacturing and R&D) to incorporate vital input into complaint reports.

• Recording and providing regulatory reportability decisions on complaints. Sr. Supplier Quality Manager-Philips Healthcare

2017-2018

• Collaborated with cross-functional teams to identify vendor requirements and selection criteria.

• Evaluated and assessed potential vendors' capabilities, financial stability, and compatibility with industry standards.

• Lead contract negotiations to secure favorable terms, pricing, and conditions with vendors.

• Collaborated with key vendors to understand needs and identify growth opportunities that benefit both parties while driving gross margin improvement.

• Developed and monitored key performance indicators (KPIs) to measure vendor performance and service quality.

• Drafted, reviewed, and managed vendor contracts, focusing on cost-effectiveness and quality, ensuring alignment with regulations and organizational standards.

• Developed and maintained vendor scorecards and managed vendor relationships towards achieving top level performance.

• Worked with the supplier on the SCARs, investigation, and resolution of root cause issues.

• Collecting, evaluating, and analyzing Quality Records data to identify gaps and risk assessment appropriately and efficiently in accordance with 21 CFR Part 820.

• Provided project direction for Supplier Quality Team, advising, correcting, and revising SOPs as needed. Sr. Supplier Quality Manager-Bayer Healthcare

2014-2016

• Supported the selection, approval, and maintenance of division's approved suppliers.

• Performed supplier quality system assessments, monitoring supplier performance, and driving supplier corrective action and activities.

• Ensured that the Division Approved Supplier List (ASL) was maintained and accurate.

• Performed on-site quality assessments of new suppliers, as required, and ensured appropriate corrective action response to findings.

• Ensured contracts addressed pricing, quality assurance, delivery schedules, and other essential terms to safeguard the company’s interests.

• Cultivated and maintained strong working relationships with vendors through effective communication, regular meetings, and collaboration.

Quality Assurance Manager -FUJIFILM Wako Diagnostics U.S.A 2012-2014

• Managed the QA team and provided technical leadership to the QA staff, ensured compliance with company quality assurance policies and practices.

• Supported supplier and customer quality and reliability activities as needed.

• Prepared documentation and chaired management review meetings and followed-up on action items.

• Lead third party audits and inspections, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.

• Monitored Trending and Analyzing Quality Indicators.

• Provided input as to appropriate corrective and preventive actions and suggesting plans for improvement.

• Implemented corrective actions to address any issues that arise.

• Provided guidance and training to staff on quality assurance standards, processes, and procedures.

• Ensured that all documentation, records, and reports are accurate, complete, and maintained in a timely manner. Complaints and Post-Market Surveillance Specialist-Abbott 2010-2012

• Responsible for assuring complaints personnel trained in all procedures and SOPs.

• Managed the end-to-end process of customer complaints including review and maintenance of complaint files for validity and assures compliance with policies and procedures.

• Coordinated complaint investigations with internal and external resources.

• Reviewed complaints for potentially reportable AE status, including evaluation and follow-up regarding MDR reporting.

• Monitoring and trending quality indicators for distributed components/products and provided quality metrics as required to generate quality system improvements.

• Responded to inquiries regarding medical device report submission associated with device malfunction or serious injury.

• Reviewed and prepared complaint files for closure.

• Participated in inter-departmental cross-functional projects. Complaint Management Specialist -Johnson& Johnson

2008-2010

• Evaluated event(s) to determine if it qualified as a complaint.

• Conducted complaint analysis investigations/reports for medical device products, ensured the process completed in accordance with standard procedures, and documented all activities.

• Reviewed complaints for potentially reportable AE status, including evaluation and follow-up regarding MDR reporting.

• Conducted trend analysis related to specific products, customers, and processes.

• Recorded and evaluated complaint submissions.

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