Quality Systems Implementation and Management, Regulatory Affairs & Compliance, Strategic Business Objectives, Organizational Excellence, Project Management, Quality Engineering,21 CFR Part 820, Part 210 & 211, ISO 13485(2016), ISO14971(2012/2019), MDSAP, MDR, IVDD & IVDR, PMS, CE Mark, 510k, De Novo & PMA (Traditional and Modular) Submissions, Technical Files/Design Dossiers, Clinical Evaluation Reports (CERs), Performance Evaluation Reports (PERs), GSPR, Quality Management System Implementation, Design and Development, Risk Management Files (RMF), Design Verification & Validation, Sterilization, CAPA, Training, Supplier Management, PAI Readiness, Internal and External Auditing /ASQ Certified Quality Auditor
Significant technical writing experience with a proven track record in project management, regulatory submissions, technical files, and writing scientific, medical/clinical, and technical content. Experience writing CERs that conform to MEDDEV 2.7/1 and the MDR.
(07/2007 to Present)
Currently contracted with various medical device companies to provide Global Regulatory and Quality System related services for compliance with the following:
21 CFR Part 820; MDSAP, ISO 13485:2016, ISO 9001:2015, ISO 14971:2012/2019, ISO 15189; the Medical
Device Regulation (MDR), the In Vitro Diagnostic Medical Device Directive & Regulation (IVDD/IVDR), including Companion Diagnostics/ CDx; IEC 60601, IEC 61010, ISO Sterilization Standards, Canadian Medical Device Regulations (CMDR), Australian Therapeutic Goods (Medical Devices) Regulations & other INTL Regulations.
Technical Senior provider for a full range of services including Quality, Regulatory, Manufacturing and Product Development related services for QMS and GxP Implementation, Design and Development/Design
Control, Risk Management, Product Life Cycle Management, SDLC, Project Management, Creation and Compilation of Design History Files, Technical Files/Design Dossiers, Clinical Evaluation Plans and Reports (CER), Risk Management Files, Validation (Design V & V, Test Method, Equipment, Process, Cleaning, Software, and Facility), Usability/Human Factors, CAPA, FDA Observations/483 Responses, FSN/FSCA, Product Failure Investigation Reports, Root Cause Analyses, Corrective and Preventive Actions, Customer Complaint Investigations, Medical Device Reporting (eMDR), Post Market Surveillance, Quality System and Supplier Audits, ISO 13485 and FDA Gap Analyses, PAI Readiness Gap Assessments, Product Transfer Activities, Supplier Management, Clinical Site Training and Pre-Sub (Q-Sub), 510k, De Novo & PMA submission preparer and reviewer. Provider for cGMP Training, Risk Management and Internal Auditor Training in Compliance with ISO 13485:2016 & FDA QSR 21 CFR 820.
Consulting services include Quality and Regulatory related services for compliance with 21 CFR, Parts 210-
- Responsibilities include quality system implementation, internal auditing, strong focus on QC and QA; validation activities focused on facility, equipment, process and test method validation activities, QC laboratory testing, OOS investigations and process improvements, data analysis and final report generation; implementation of environmental monitoring programs, CAPA & nonconformance investigations/root cause analysis, and implementing process improvements and training programs.
Head of Quality & Regulatory (08/2020 to Present) Rockville, MD
CytoTest Inc is a biotechnology company providing high quality, innovative and affordable molecular cytogenetics products. Quality and Regulatory executive leadership for a small privately held business in order to accelerate the growth strategy and improve compliance. Successfully obtained ISO13485:2016 recertification and implemented a robust design and development process for new product development. Currently implementing quality assurance and regulatory affairs programs to lower their overall compliance risk as well as creating CE Technical Files for CE marked products (Class C) in accordance with the EU IVDR. Providing leadership, training & guidance to enhance and promote quality and build a culture of quality and regulatory compliance.
CRYOCONCEPTS, LP (05/2010 to 09/2020) Bethlehem, PA
VP, Quality & Regulatory
Quality and Regulatory executive leadership for a cryosurgery medical device (Class IIa) and cosmetics privately held company. Implemented the Quality Management System, including a robust, risk based supply management system, systematic design and development process, risk management program, and validated electronic quality system for efficiency and productivity. Led the design and development process and regulatory clearances/approvals both domestically and internationally. Led manufacturing operations, product development, and quality operations and teams through nearly seamless audits for ISO 13485, MDSAP and FDA Inspections. Updated and implemented the QMS and Technical Files for MDR compliance. Successfully completed a new product acquisition in terms of QMS deliverables and Regulatory submissions and updates for the US, EU, AUS, Brazil and 12 other international countries.
NANOSTRING TECHNOLOGIES Seattle, WA
Interim Head of Quality (10/2017 to 09/2018)
Quality/Regulatory/PMA/PAI Readiness Executive Consultant (05/2017 to 12/2019)
Interim Head of Quality for NanoString Technologies, a publicly held biotech company focused on translational medicine, in vitro diagnostic applications and research specializing in cancer diagnostic tools. Successfully restructured and implemented improved effective processes for Design and Development and Risk Management for both the product development diagnostic group and the R & D group. Directly accountable for corporate compliance to 21 CFR Parts 820 and achieving ISO13485:2016 and MDSAP certification.
Additional Quality/Regulatory/PMA/PAI Readiness Executive Consultant responsibilities were primarily focused on Nanostring’s CDx assay platform for FFPE tumor tissue using multiplex gene expression assays on instrument analysis systems (Assay, Instruments, Software). Partnered with design and development to achieve quality and regulatory goals for all projects. Core Team Member on all CDx design projects, and PMA technical writer. SME for Quality and Manufacturing content for the PMA. Provided Quality, Regulatory and Clinical input and guidance to cross functional project teams in support of the development of Companion Diagnostics in collaboration with pharmaceutical partners.
GI SUPPLY INC (03/2013 to 04/2017) Camp Hill, PA
VP, Quality & Regulatory
Quality and Regulatory executive leadership for a diverse gastroenterology medical device company including sterile implantable medical devices and IVDs. Implemented FDA and ISO 13485/9001 quality management systems. Complete quality and regulatory responsibility for the design, manufacture, packaging, and distribution of gastroenterological medical devices. Managed and planned functional activities with Operations, Marketing and R & D to achieve departmental and strategic company initiatives. Focus was on the development and execution of new product development, risk based supply chain management, manufacturing process improvements from end to end, MDD and IVDD compliant Technical Files, robust Clinical Evaluation Reports in compliance with the MEDDEV 2.7/1 (Rev 4) including execution of supporting clinical studies and PMCF studies. Successful regulatory submissions and approvals obtained for multiple GI products both domestically and internationally. Successfully achieved ISO13485:2016 certification and EC certification (CE mark) on multiple products.
PMD HEALTHCARE (11/2015 to 01/2017) Allentown, PA
Head of Quality & Regulatory
PMD Healthcare is an electrical medical device company focused on providing portable and affordable personal medical devices specifically for monitoring lung function. Quality and Regulatory executive leadership in remediation activities for the Quality System, Design History Files and Technical Files. Successfully appealed certificate suspensions and implemented sustainable, efficient and compliant systems with 21 CFR Part 820 and ISO13485:2016. Provided leadership in enhancing quality and building capabilities of less experienced staff.
SALADAX BIOMEDICAL INC (06/2014 to 08/2015) Bethlehem, PA
Head of Quality
Saladax, a precision medicine company, develops rapid blood tests to increase the impact of personalized medicine by bringing adherence testing to psychiatrists and chemotherapeutic drug monitoring to oncologists. Provided Quality leadership for the design & development and manufacture of IVDs and quality oversight was provided for the CLIA laboratory. Activities were focused on partnering with product development for the design and development of several oncology drug monitoring assays and defining, planning and executing operational activities related to the quality systems for the medical device manufacturing and CLIA laboratory testing, specifically Laboratory Developed Tests (LDTs).
CERORA INC (09/2013 to 12/2016) Bethlehem, PA Head of Quality & Regulatory
Cerora’s medical device platform focused on EEG activity as well as other biosensor data, including cognitive data to aid in the diagnosis and management of various brain disorder, injuries and diseases. Led the implementation of the quality system (21 CFR Part 820 & ISO13495 compliant) and development of a robust Design and Development system including software development. Partnered with design engineering firms to collaboratively plan and execute design control activities, including risk management.
NEUROMONICS INC (04/2009 to 12/2014) Bethlehem, PA / Westminster, CO VP, Quality & Regulatory
Neuromonics designs, manufactures and distributes medical devices designed for long-term, significant relief of tinnitus. Provided Quality and Regulatory executive leadership to accomplish quality and regulatory goals and company strategic initiatives. Led quality teams in the US and Australia in
transforming the quality system to increase efficiency and meet US and AUS regulations and minimize risk. Collaborated and partnered with product development to implement an improved, structured approach to design and development including risk management. Implemented a robust post market surveillance (PMS) program in collaboration with technical services and marketing to provide key essential reporting on current products on a compliance and business perspective.
TUNSTALL AMERICAS (01/2012 to 03/2013) Long Island City, NY
Head of Quality & Regulatory
Tunstall provides technology based solutions and services to improve and deliver new, more efficient and effective models for health & care management in the community setting. Provided Quality and Regulatory transformational leadership. Focused on building and delivering quality strategy & quality culture. Provided coaching and mentoring to develop high performing teams with a focus on quality, risk management and meeting company objectives. Implemented a 21 CFR Part 820 and ISO13485 quality system. Proactively managed and applied risk management to mitigate risk and achieve quality outcomes in alignment with the corporate strategy.
ORASURE TECHNOLOGIES, INC (07/2007 to 01/2009) Bethlehem, PA
Partnered and collaborated with multiple departments to achieve company strategic goals. Provided Quality, Regulatory, R and D and Operations related services as required for Design Control Projects, Design History File Documents, Technical Phase Reports, Validation Master Plans, Validation Protocols (Test Method, Process, Cleaning and Equipment), Shipping and Stability Study Protocols and Final Reports, Process Capability Analysis, Product Failure Investigation Reports, Root Cause Analyses, Corrective and Preventative Actions, Customer Complaint Investigations, Gap Analyses, Product Risk Analysis Evaluation and Review, Product Development Support, Product Transfer activities, Clinical Site Training, Pre-Subs (Q-Subs), PMA Submissions, Technical Transfer and Validation.
ORASURE TECHNOLOGIES, INC (11/2001 to 07/2007) Bethlehem, PA
Director, Quality Control (01/2003 to 07/2007)
Directed corporate and plant wide quality control labs and partnered with quality on quality systems activities for an IVD medical device company manufacturing PMA and 510K devices. Led cross functional teams focused on process improvements and efficiencies in operations. Worked closely with the product development teams on all new products and design changes to existing products. Integrally involved with product development in project management and worked collaboratively with Regulatory on regulatory submissions, technical files and writing scientific, medical/clinical, and technical content. Worked closely with the CDC on new product rapid testing implementation. Developed and implemented quality programs for validation, stability, process monitoring, SPC, OOS, risk management, risk based supplier management and sustaining engineering. Substantial focus on coaching and mentoring staff to build experience, knowledge and capabilities in QC and other departments.
Quality Control Manager (11/2001 to 12/2002)
Responsible for all quality control related operations from incoming raw material through manufacturing and further to the release of final products. Designed and implemented a microbiology lab including the implementation of an environmental monitoring program, including viable and non-viable monitoring, bioburden testing. Designed test method, and equipment validations for all Quality Control Labs and process and equipment validations for Manufacturing. Active core team member on all Design Control teams for new products. Implemented a robust inspection process based on statistical sampling for incoming inspection of raw materials and in-process and finished products. Directly involved in all on-site FDA/CBER inspections and the technical writing for Design History Files and regulatory submissions.
MILLER MEMORIAL BLOOD CENTER, (08/1998 to 11/2001) Bethlehem, PA
Product Manager / Apheresis Manager
Manager of the Component Laboratory, Product Management and Apheresis Departments. Responsible for apheresis collections, product management and component manufacturing in terms of productivity, product
quality, and customer satisfaction. Responsible for obtaining FDA licensure for all new and existing products. Reviewed all potential and existing customer contracts for economic and manufacturing feasibility. Created, maintained and utilized self assessments to monitor processes and perform process improvements based on trend and comparative analysis. Manage and develop personnel specific developmental goals that were company progressive focused for team of 24. Generated month quality control, manufacturing and productivity metrics. Representative on the Material Review Board (MRB). Ensured appropriate product inventory, products meet quality standards and high levels of customer satisfaction.
EASTON HOSPITAL Easton, PA
Clinical Technician Supervisor (04/1997 to 08/1998)
Responsibilities include direct supervision of 34 technicians on a 7 day, 24 hour operation. Provided technical support for the lab, cardiology, medical staff, and the admissions department.
LEHIGH VALLEY HOSPITAL, Allentown, PA
Medical Technologist, Generalist (05/1988 to 06/1996)
EASTON HOSPITAL, Easton, PA
Medical Technologist, Microbiologist (03/1986 to 05/1988)
Education and Professional Development: SHIPPENSBURG UNIVERSITY
Bachelor of Science in Medical Technology (May 1985)
Professional Certification Memberships:
ASCP, Medical Technologist (August 1985), Certification Number: MT–164666
ASQ Certified Manager of Quality/Organizational Excellence, Certification Number 16609 ASQ Certified Quality Auditor, Certification Number 43622
RAC, Regulatory Affairs Certification
ASQ Member: American Society for Quality
RAPs Member: Regulatory Affairs Professional Society
Abstract: Performance of a Rapid Point of Care Test for HIV Antibodies. Topic: Infectious Disease, S.L. Lee, Ph. D., Geraldine Guillon, Ph. D., Gloria Ferko, Christine DeTurk, Melissa Hershberger, Tracy Marshall, Keith Kardos, Ph. D. POCT Infectious Disease Symposium, Quebec, September 2006
NCC Biotechnology Advisory Committee Member (2003-2008) LCCC Biotechnology Advisory Committee Member (2003-2006)
Institute for Quality in Laboratory Medicine (IQLM) – Technology Partner Representative for OraSure Technologies (2005-2007)
Guest Lecturer: Clean Room Design, Validation and Monitoring – Lehigh University, Bioengineering Curriculum, February 2006
Guest Lecturer: Introduction to Good Manufacturing Practices, “Investigating and Writing Failure Investigations and Performing Root Cause Analysis” – Northampton County Community College, February 2009
Guest Lecturer: Introduction to Good Manufacturing Practices, “An Overview of ISO9001:2008 & ISO13485:2003 Standards” - Northampton County Community College, April 2009