Quality Control Medical Device

ROB TEETER

**** **** ***. **

Everett, WA *****

425-***-**** *********@*******.***

REGULATORY AFFAIRS SPECIALIST

Success through Personal Leadership and Technical Experience

SUMMARY

Driven to achieve goals and overcome obstacles, confident, highly energized, effective and persuasive

communicator with strong interpersonal and technical skills. Recognized for a successful track record

and thirty years of experience in Class III medical device manufacturing including operations, quality

assurance, quality systems, and compliance engineering . Noted and rewarded for being hands-on,

focused, with much experiential knowledge, and having a diverse, highly technical background.

Accustomed to adversity, resistant to rejection, and practiced in the patient and consistent attainment

of personal and professional goals. A turnkey solution provider who consistently earns the confidence

of both customers and staff, through the delivery of superior support before, during, and after the

project has been completed.

• Highly experienced and successful leader recognized for consistently delivering quality systems

certifications and fully compliant products. Frequently selected to work on challenging projects and

rapidly develop solid, working relationships through the use of innovative and imaginative programs

designed to achieve maximum success and confidentiality .

• A top resource in medical devices and technology fields who is skilled in developing exceptional

internal relationships through personal example and real life experiences. Outstanding reputation is

based on grass-roots street smarts, strategic technical knowledge and product expertise.

CORE COMPETENCIES

Test and Calibration • Design • Medical Devices • Project Management

Quality Control • Documentation • EU Marketplace • Compliance

SAP • Manufacturing • Auditor • Calibration • Surface Mount Technology

ISO13485 • Laboratory Supervisor • PLM Systems

Regulatory Affairs

EXPERIENCE

PHYSIO CONTROL Inc. Seattle, WA 1981-2009

A pioneer in defibrillation technology

Regulatory Affairs Specialist 2000-2009

Delivered key technical and regulatory advice and support to the global electronic medical device

market. Created, reviewed and established Technical Documentation Files for CE Marked Class IIb, II

and I devices for the EU market, and delivered and ensured compliance with QSR, SOR/98-282, PAL,

MDD 93/42/EEC, FAA TSO-C142, ISO 17025:2005, and ISO 13485:2003.

• Obtained multiple market clearances and approvals in 135 countries for 2 different multiparameter

cardiac monitor defibrillators and OEM accessories. Japan alone had 8 separate product submissions.

Rob Teeter Page

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Experience Continued

• Initial establishment of quality system procedures relevant to Title 14 CFR, ensuring FAA TSO-C143

compliance for Lithium Manganese Dioxide battery packs for Automatic External Defibrillators installed

aboard civil and military aircraft.

• Sr. contributor on a development team tasked with implementing SAP processes for worldwide

distribution controls for all manufactured and distributed medical devices. 60000+ UPNs were identified,

cataloged and had additional data entry coded to allow upload for Western EU customers.

• Delivered quality system expertise for TUV ISO13485 audits as well as for TUV CMDCAS audits.

• Key contributor for CSA ISO17025 audits.

Quality Systems Internal Auditor 1997-2000

• BSI Certified ISO9001 lead assessor. Crucial delivery of first vertical internal audit in company history and

performed QSR:1996 Part 820 decomposition and gap analysis.

• Hosted 3rd party quality system assessments for global regulatory agencies.

Calibration Services Auditor 1995-1997

• Developed calibration services audit process and operating procedures.

• Audited 23 suppliers in 2 years per MIL STD 45662a. Reduced supplier base by 25%, saving the company

$40,000.00 per year in audit expenses.

Management/Supervision 1993-1995

• Calibration Laboratory Supervisor overseeing 2 Metrologists, 3 Technicians, 1 admin, and approximately

4000 instruments.

• Staff responsibilities included managing, training, mentoring, developing and tracking employee

performance and deliverables.

Surface Mount Technologist 1986-1993

Weekend Shift Coordinator (QC Tech. III) 1984-1986

Quality Control Tech II 1983-1984

Quality Control Tech I 1981-1983

HARDWARE AND SOFTWARE

eCentrals PLM system, MFG Pro, Global Trade Services (GTS) Distribution Control Module within

SAP, Documentum, Microsoft Office 2007

EDUCATION

DeVry Technical Institute, Phoenix AZ – Electronic Technician Program

RECOGNITION AND AWARDS

Multiple award winner for work regarding implementation of Japanese requirements under the

Pharmaceutical Affairs Law, (I became the subject matter expert). Received recognition for

implementing FAA requirements for Lithium Manganese Batteries under Title 14 CFR, (I became

the system owner). Received recognition for support during our TUV facility assessments

investigating CMDCAS requirements for Canada,(I became the subject matter expert).

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