WAYNE FIELDS, PhD

***** ** ****** **** *********, OR 97222 503-***-**** abnxn3@r.postjobfree.com

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DEVICE QA/RA CONSULTANT

ISO/CMDR/MDD regs & compliance; Create/Maintain QMS; Technical Files,

Submission Documents; CE Mark / CE Certification; Agency interactions

Ensure compliance to meet pivotal Quality Assurance & Regulatory Affairs Requirements

Deliver success through results-driven QA/RA Direction and/or conduct, including timely strategy, design, creation, direction, analysis, continuous improvement & cost control. Strong technical savvy and solution visionary. Deliver integrated solutions within and between departments, by sparking positive professional relationships at all firm levels & inspiring unified action. with executive, design, quality & marketing associates. Highlights include:

o Twice created & maintained a full QMS;

o Authored four 510(k)s; all cleared;

o Solid understanding of standards, Regulations, Guides;

o Directed/Wrote Technical File used to attain CE Mark;

o Risk Analyses centered on FMEA and/or ISO 14971;

o Strong verbal & written communications.

EMPOWERING PROFICIENCIES

Architect Career features leadership, longevity;

Groups Team anchor, driving unity & success;

Compliance Enact practical systems that meet plan;

Product Development/design specialist;

Support Conduct efforts that others lead;

Literature Unify technical & clinical evaluation.

CAREER HISTORY

THERMOGEAR INC, Portland,

Oregon 2003-2012

Manufacturer of portable personal warming systems (military; medical; veterinary; consumer)

Director, Quality-Regulatory Dept

Developed inaugural Quality-Regulatory Dept. from ground up, based on FDA QSR. Later, revamped QMS to meet ISO 13485. Devised& implemented Risk Management; headed FMEA & ISO 14971 analyses; built Technical File to acquire CE / CSA Marks & ISO 13485 certification. Devised / directed full CAPA program, integrating findings into Management Review & product design. Helped write & manage contract manufacturing / marketing & sales / fulfillment agreements. Created / directed Training program. Led &/or carried out all other Quality-Regulatory issues. Examples of Enterprise Impact:

● Derived successful plan where contract manufacturing / marketing / fulfillment contractee carried all costs; saved $500K;

● Saved $1M in outsourcing by developing two QMSs; three 510(k)s; acquired Marks (CE; CSA) & ISO 13485 certification;

● Drove Management Review & all other annuals, saving $10K-60K/yr long-term while showing continual improvement;

● Designed / led three judicious technical outsourcings; to speed Marks needed for sales (generated $200K extra revenue);

● Directed internal / external audits, integrated results into the CAPA program &, as appropriate, QMS-design improvement.

Venture Solutions Ltd (VSL), Lake Oswego, OR 1987-2003)

Provided early product planning, business development, & funding help for diverse small startup & pre-startup enterprises.

Co-Owner & Operations Director

Working with co-owner, recruited all projects, determined technical feasibility, market potential, and enterprise structure. For suitable projects, wrote (myself only) a self-designed business plan approach, including a detailed financial model. Co-owners, as appropriate, helped client incorporate, guided / aided design & prototyping of product / service, testing & user evaluation, & search for funding. Served early projects needing key guidance or reality checks. VSL formed to provide needed consultation where none existed before, & as a platform to seek projects with significant potential for co-owner involvement (Univend Inc arose in this way; see later). Examples of Enterprise Impact:

● Developed generic structure for narrative & detailed financial modeling for diverse business plans tailored to each project;

● Used 2nd partner’s separate product marketing analysis business as one source of clients, serving as an alternative path;

● Many recognized professionals respected VSL as an honest talented source of help for the little guy.

Univend Inc, Tualatin, OR 1990-1995

Inventor & producer of breakthrough single-vend newspaper dispensing machine

Co-Owner, Active in Planning, Design & Funding

VSL co-owners joined a metal fabrication firm owner to invent a commercial newspaper dispensing machine that delivered only one paper at a time. Competitive machines were ubiquitous, but user had access to all newspapers with every inserted coin set (nationally, thefts equaled up to 15% of sales). Led business development with VSL partner, conceived funding plan (find a metal fab shop that would invest time/money), & aided design. Examples of Enterprise Impact:

● Created plan to find an investing industrial metal fab facility owner to join the Univend ownership team;

● With fab shop owner, worked with original idea man to design & prototype product; saved $500K+ in outsourced design;

● Helped Univend partners develop parts supply & manufacturing; singly developed promotional material;

● VSL co-owners developed / implemented a marketing/sales effort, letting large newspaper firms evaluate prototypes.

Premium Equity Corp, Vancouver, B.C. 1984-1988

Provide proprietary device and also device-based clinical rehabilitation for stroke patients

VP Technology

Directed engineering planning, design, manufacturing & QA/RA for clinical device. Ensured the design meshed with in-house use by Company clinical personnel. Oversaw Company clinics set up to provide the extended therapy, and helped develop clinical protocols to define patient initial baseline & treatment end-point. Wrote a peer-reviewed journal article about the device & treatment, tagged as a breakthrough clinical approach. Examples of Enterprise Impact:

● Based on treatment concept of Physical Therapist idea-man, conceived nature & detail of business development;

● Design development and implementation (outsourced cost est $150K);

● Directed design transfer, production, and QA/RA for the proprietary device (outsourced cost est $150K);

● Authored a 510(k) for the clinical device that cleared FDA in less than two weeks;

● Authored and maintained a robust financial model for the entire enterprise.

EDUCATION

Ph.D. in Physiology, School of Medicine, Oregon Health & Science University

B.S. in Science (strong emphasis in the physical sciences), Oregon State University

PROFESSIONAL DEVELOPMENT

Noblitt & Rueland (2007-2010): 1-3-day Training Seminars in QSR/GMP, ISO 13485, ISO 14971, CE Mark, Design Control;

BSI (2009): 3-day ISO 13485 Training Course on Quality Manual Creation & also Auditing;

Medpoint University, ISO 13485 content, interpretation & implementation

RAPS Membership & many annual meetings: 2005-present;

PATENTS

Four Patents, primary or secondary author (Titles are descriptive, not actual):

5,205,437, Newspaper Dispensing Machine that Delivers One Paper per Coin Set;

5,300,096, Re-enable Arm Motor Action &Sensory Feedback using Electrical Stimulation to aid Stroke Patient Rehabilitation;

7,319,207, Outdoor Portable, Rechargeable Electric Heating Blanket; and

7,959,658, Means to Deliver Different Heating to Distinct Heating Zones in a Portable Electric Blanket.

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