Quality Assurance and Regulatory consultant and contract engineer for Medical Device Industry• Quality system implementation• Quality System updates for ISO 13485:2016, European Union Medical Device Regulation 2017/745 and other new/changing regulations• Quality system/product quality improvement and remediation• Verification and Validation• Sustaining engineering and cost reduction• New product development and design control

Provide Regulatory Affairs, Quality Engineering and Quality System consulting for the medical device industry including QMS implementation, management, integration, gap analysis and remediation; Risk management; Design Control and technical file documentation.

Senior Quality Engineer - Industrial• Principle Quality Assurance representative for new product development projects including generation, review and approval of documentation for design history file, technical file and regulatory submissions • Primary Quality Engineer for a high volume product line including review/approval of post-transfer changes, investigation/disposition of non-conformances and implementation of corrective actions• Participate in quality system audits by FDA and other regulatory agencies including preparation, direct interaction with auditors, strategic planning and resolution of non-conformances• Perform on-site quality system and product quality audits of suppliers, generate audit reports and work with suppliers to resolve non-conformances • Gather, analyze and present data to global management demonstrating compliance with the quality management system, applicable regulations and business objectives Senior Quality Engineer - Commercial• Led a team of quality engineers and technicians in completing complaint investigations as well as adverse event reporting for a wide variety of medical devices used in cardiac surgery• Generate, review and approve technical file documents such as risk assessments, post-market surveillance, change orders, complaint files and non-conforming product reports• Led the implementation of custom complaint handling software for 5 facilities in 4 countries including system development, validation, implementation and training• Track/trend product failures to identify quality issues and act as the QA representative in the implementation of product/process improvements identified through post-market feedback

• Generate and execute documents to support regulatory submissions for new and established medical device manufacturers such as design verification and processes/equipment validation plans and reports• Participate in and provide strategic input on quality systems implementation/remediation projects for a variety of medical device companies ranging from start-ups to large global corporations • Review and approve complaint files, non-conforming product reports, risk analyses, change orders, standard operating procedures and laboratory test protocols