Senior Director

Quality and Regulatory

â⠬ŠJeff took us from a motorcycle gang to a marching band with scalable processes.â⠬Â
Dirk Soenksen
Chief Executive Officer-Aperio Technologies
QUALIFICATIONS PROFILE
Experienced and self-driven professional with 25 years of progressive background
in overseeing and executing quality and regulatory compliance initiatives in hi
gh growth medical device companies. Exemplified advanced expertise in applying q
uality tools with verifiable record of success in developing and implementing in
dustry directives to ensure quality and service excellence. Results-based expert
ise in strategy execution combined with skills in leading and managing organizat
ional quality and compliance. Equipped with superior interpersonal skills; compe
tent at working efficiently in both individual and collaborative environment whi
le maintaining high quality work performance. Recognized for developing a health
y quality culture distinctively suited for an organization.
NOTABLE ACCOMPLISHMENTS
- Ensured complete implementation of quality management systems that resul
ted in full compliance with all customer and regulatory requirements without any
non-conformance issued for initial and subsequent audits
- Successfully minimized external failure rates by more than 10% in less t
han one year
- Commended by Federal, State FDB, ISO, and customer auditors for the effi
cient design and documentation of quality management systems with particular emp
hasis on design control, CAPAs, and management review
- Thrived in receiving clearance for 510(k) submissions: K071128, K071671,
K073777, K080254, K080654
- Implemented a fully compliant medical device design and manufacturing qu
ality management system into an existing global operation
- Obtained certification as ISO 13485:2003 Lead Internal Auditor, CQE, CQA
, RAC
CAREER OVERVIEW
- Provided proactive leadership in overseeing and implementing all quality
, regulatory, and clinical functions as well as all facets of corporate complian
ce program
- Designed and executed annual domestic and international quality and regu
latory strategies for multiple sites; presented metrics and reports to Executive
Council and Board of Directors
- Administered and resolved manufacturing and global regulatory issues
- Directed all efforts to continually improve and implement quality manage
ment and regulatory systems for various-sized medical device manufacturers as we
ll as elements of the quality systems, including design development, document c
ontrol, audit programs, CAPA systems, validation, and GXP compliance processes
- Functioned as corporate representative for quality and regulatory functi
ons during all phases of product development and developed associated quality an
d regulatory deliverables
- Recognized as principal liaison and management representative for all in
teractions with Food and Drug Administration (FDA), California Department of Pub
lic Health (CDPH), International Organization for Standardization (ISO), and oth
er regulatory agencies
- Assumed full responsibility in ensuring complete conformity with custome
r and regulatory requirements, including quality system regulations (21 CFR 820)
, ISO 13485:2003, MDD 93/42/EEC, IVDD
- Incorporated safety risk management efforts in accordance with ISO 14971
:2007 requirements
- Established strong workforce through recruiting and developing highly co
mpetitive quality, regulatory, and compliance staff in support of company object
ives
WORK CHRONOLOGY
Senior Director of Quality and Regulatory
Aperio Technologies ~ Vista, CA July 2006-Present
Director of Quality Assurance and Compliance
REVA Medical Corporation ~ San Diego, CA Dec 2001-June 2006

Quality Manager
Quidel Corporation ~ San Diego, CA May 1999-Dec 2001
Director of Operations
Codeline Corporation ~ Escondido, CA May 1996-Apr 1999
Quality System Senior Manager
U.S. Medical Instruments, Inc. ~ San Diego, CA Jan 1995-May 1996
Corporate Quality Assurance Manager
Baker Equipment Engineering Corporation ~ Richmond, VA Oct 1991-Dec 199
4
Quality Manager
IMED Corporation ~ San Diego, CA Mar 1981-June 1991
EDUCATION
Bachelor of Science in Business Management (GPA: 3.83), University of Phoenix ~
San Diego, CA ~ 2008
PROFESSIONAL DEVELOPMENT
ISO 14971:2007 Risk Management Training
Design and Process Failure Modes Effects and Criticality Assessment
ISO 13485:2003 Lead Quality Management System Auditor Training
Design Control for Medical Devices
510K and PMA Submissions for Regulatory Professionals
Kaizen for Manufacturing, Service and Administration
Statistical Process Control
AFFILIATIONS
Senior Member, American Society for Quality (ASQ)
Member, Regulatory Affairs Professionals Society (RAPS)
Member, AdvaMed
CERTIFICATIONS
Certified Quality Engineer (CQE), American Society for Quality (ASQ)
Certified Quality Auditor (CQA), American Society for Quality (ASQ)
Regulatory Affairs Certified (RAC), Regulatory Affairs Professionals Society (RA
P)
TECHNICAL ACUMEN
Proficient with MS Office applications (Word, Excel, Project, PowerPoint, and Ac
cess)