EDUCATION:
Old Dominion University, Norfolk, Virginia
M.B.A., Finance Concentration, 1999

UNITED STATES COAST GUARD ACADEMY, New London, Connecticut
B.S., Naval Architecture and Marine Engineering, 1992

CERTIFICATIONS:
Past ASQ Certification in Quality Engineering (CQE) and Reliability Engineering (CRE)

ASSOCIATION MEMBERSHIPS:
RAPS and Former ASQ Section Chair

An innovative and forward-thinking leader, with a demonstrated record of building great companies while reducing risk, improving quality, increasing compliance, and growing revenue with margin expansion.

Vice President, Quality Management System Consulting (Quality and Regulatory Affairs)
ELIQUENT Life Sciences
2019-Present
Responsible for providing Life Science organizations globally with consulting, training, and audit support (including the remote and virtual environment) to achieve compliance with US FDA and global regulations like EU MDR and EU IVDR.

Global consulting client support for industry leaders on Quality Management System (QMS) implementation and
development for Class I/II/III Medical Device Manufacturers (including Combination Products and some Pharma).

Provide onsite and virtual expertise and training on all areas of Life Science subject matter expertise (examples
include EU MDR, MDSAP, ISO 14971 Risk Management, ISO 13475 Lead Auditor, CAPA, Supplier Quality, etc).

Subject Matter Expert with Global Medical Device Regulations such as but not limited to US
(21CFR820/803/806/Part 4& 11), Australia, Brazil, Canada, Japan, EU MDR/UK, China NPMA (formerly CFDA) with proficiency in India, Taiwan, Thailand, Part210/211, ICH Q series (Combination Products/Pharma), etc.

Implemented M&A Due Diligence playbook and led QA/RA research, report and recommendations to C-suite for global medical device company that resulted in $1B+ divesture and sale with carve outs for risk protection.

Directed development, communication, implementation, and continuous improvement of remote audit program
during global pandemic to ensure continued delivery of client audit services to assess compliance to global medical
device quality system regulations and standards (when no onsite services available worldwide).

Recognized collaborator and communicator, created and led a team to improve global communications from a 81
to a perfect 100 according to Great Places to Work (95 is considered best in class) which was published (2/ 2022).

Vice President Quality Assurance, Compliance and Legal
Orchid Orthopedic Solutions
2012-2019
Oversaw legal, compliance, and global risk management, as well as the portfolio of patents and trademarks. Started as Director of Quality and Compliance, with global responsibility for 12 sites on 2 continents. Promoted to C-level executive in 2013 as Vice President of Quality and Regulatory Compliance and officially assigned to the executive team. Global oversight increased with acquisition to a total of 15 site locations on 4 continents. Led dismissal of five product liability cases and navigated a very difficult FDA inspection.

Appointed by the Board of Directors as company officer in 2018 and director and manager for 11 corporate entities, along with additional responsibilities as head of legal, risk management (including commercial insurance), and environmental health and safety. Instrumental in legal role, in addition to quality, compliance, insurance, and environmental health and safety due diligence/interviews for private-equity sale of company to Nordic Capital in 2019 and assumed additional managing director positions.

Created, integrated and directed global quality organization with a collaborative style built on trust to a single aligned vision, implemented talent assessment and management at 15 global locations, and led up to 15 senior-level managers/engineers and 200 total quality personnel.

Created regulatory compliance education and audit program for 2,000 employees, leading 15 global sites to
compliance with all applicable federal, state, and local laws while hosting 21 FDA inspections (126 audits days), with
average observations well below FDA published average, including eight inspections with zero observations.

Hosted 21 compliance inspections (126 audits days), with average observations well below published average, including eight inspections with zero observations.

Re-designed Order Entry process using Lean principles. Resulted in a 30% decrease in error rate and an increase in productivity within Sale and Client Coordinator departments.

Supported 50 active large scale client accounts while also meeting a $400,000 individual sales goal.

Program managed all strategic client implementations of on-site consulting and training which increased levels of client retention and satisfaction by 67%.