Ashley Sinclair
West Chester,OH
Summary
Results-driven Quality Assurance Engineer and Project Manager with 8+ years of experience in quality management, supplier management, regulatory compliance, and process improvement. Demonstrated expertise in implementing and managing ISO- and FDA-compliant Quality Management Systems (QMS), supplier qualifications, audits, CAPA management, root cause analysis. Skilled at driving process improvements and fostering cross-functional collaboration . Eager to contribute technical knowledge and leadership to enhance quality systems and supplier partnerships.
Overview
15
15
years of professional experience
Work History
Quality Assurance Consultant & Project Manager
Novus Management Group, LLC
Blue Ash, USA
09.2016 - Current
- Responsible for client management and establishment of Quality Management Systems for clients ensuring regulatory compliance to applicable regulations including: US 21 CFR (Code of Federal Regulations) part 820 (Quality System Regulation), Regulation (EU) 2017/745 (European Regulations on Medical Devices) & Regulation (EU) 2017/746 (European Regulations on In Vitro Diagnostic Devices); ISO 13485:2106 (Medical Devices – Quality System Management), and ISO 14971 (Medical Devices – Applications of Risk Management to Medical Devices)
- Performing and documenting root cause analysis for nonconformance reports (NCRs), Corrective Actions and Preventative Actions (CAPAs), Complaints, & Audit Observations (AOs);
- Conducting Hazard Analysis (HTM) as part of design control activities
- Qualified suppliers to ensure compliance with regulatory requirements, driving improvements through supplier performance ratings and corrective actions
- Successfully supported internal and supplier audits
- Managed supplier CAPA requests, performed root cause analysis, and executed supplier evaluations for Management Reviews
- Configured and implemented electronic document management systems, including MasterControl, enhancing QMS efficiency
- Successfully supported ISO 13485 and FDA certification audits, ensuring ongoing compliance
- Promoted and executed quality standards, inspection processes, quality plans, protocols and reports
- Managed the deliverance of training on quality standards, regulatory requirements, and process improvements to cross-functional teams
- Key Projects:
- Alcyone Therapeutics: Ongoing support in maintaining their quality management system (QMS), aiding in adhering to regulatory standards, collaborating with cross-functional teams to identify and address potential quality issues, and driving continuous improvement initiatives
- CoRISMA: Quality support by fulfilling Director of Quality Assurance position for the development of and oversight of an electronic Quality Management System for an implantable cardiac heart device
- Oversaw design reviews, CAPAs, and supplier qualification
- GestVision, Inc.: Led quality initiatives for the GestAssured Kit, an in vitro diagnostic device to aid in the diagnosis of preclampsia, achieving ISO 13485 certification
- Obsidio Inc.: Supported QMS development for a novel vascular embolization device, contributing to FDA clearance in 2022
- Heart Biotech Holdings: Spearheaded QMS development and implementation for medical devices compliant with US 21 CFR, ISO 13485 and EU 2017/745
- EMAIGE: Provided data analysis performing patient scans for an orthopedic diagnostic device at Mercy Health Physical Therapy locations
Bar Manager
Con Murphy’s Irish Pub
Philadelphia, USA
09.2009 - 01.2016
- Enhanced operational efficiency and customer satisfaction by streamlining inventory management and staff training
- Increased revenue by developing and promoting innovative marketing strategies and cocktail concepts
Education
Social and Human Service Assistant Certificate -
Community College of Philadelphia
05.2016
Patient Service Representative Certificate -
Community College of Philadelphia
05.2016
B.S. - Business Administration, Focus: Healthcare Administration
Temple University, Fox School of Business
Philadelphia, PA01.2012
Skills
- Regulatory Compliance (FDA, ISO, EU MDR/IVDR)
- Supplier Qualification
- Quality Management Systems (QMS) Implementation
- Root Cause Analysis & CAPA Management
- MasterControl Configuration
- Leadership & Team Collaboration
- Analytical Thinking & Problem Solving
- Microsoft Office Suite (Word, PowerPoint, Excel)
- Training & Development
- Supplier relationship management
- Auditing techniques
Accomplishments
- Successfully Developed, implemented, and managed FDA and ISO compliant Quality Systems for multiple medical device companies.
- Successfully led audits and implemented improvement plans to meet industrial standards of excellence.
- Delivered measurable supplier performance improvements through targeted action plans and data-driven analysis.
- Played a critical role in multiple clients’ ISO 13485 and FDA certification successes.
- Streamlined QMS processes, reducing nonconformances and improving compliance timelines.
Timeline
Quality Assurance Consultant & Project Manager
Novus Management Group, LLC
09.2016 - Current
Bar Manager
Con Murphy’s Irish Pub
09.2009 - 01.2016
Social and Human Service Assistant Certificate -
Community College of Philadelphia
Patient Service Representative Certificate -
Community College of Philadelphia
B.S. - Business Administration, Focus: Healthcare Administration
Temple University, Fox School of Business
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