Management Manager

Mike Wodstrchill

Email: abosqa@r.postjobfree.com

Address: ***** **** ****

City: New Port Richey

State: FL

Zip: 34654

Country: USA

Phone: 727-***-****

Skill Level: Management

Salary Range: 50

Willing to Relocate

Primary Skills/Experience:

See Resume

Educational Background:

See Resume

Job History / Details:

Overview:

Experienced Management Representative with highly competitive quality management systems, technical and team management experience, and in-depth experience of product management, resource optimization, product lifecycle management, technology and strategic planning spanning diverse industries. Recognized for ability to lead teams in developing new products and quality systems to achieve positive outcomes, enabling substantial market share growth. Results driven, diplomatic professional able to work effectively in teams or independently to meet and exceed business as well as customer needs; proven records of success.

Professional Strengths Include:

Regulatory Compliance, All Aspects

Product Management,

Product Manufacturability,

Customer Driven Management,

Market Research,

Cross Functional Management,

Product Development,

Product Lifecycle Management,

New Business Development,

Department Startup and Compliance

Mediation, Support, Conflict Resolution

Team Leadership

EDUCATION

Ashford University, Clinton, IA

B.A. Organizational Management

with Distinction

Villanova University, Villanova, PA

Lean Six Sigma Black Belt

British Standards Institution, Reston, VA

ISO 13485:2003 Lead Auditor

National Quality Assurance USA, Tampa, FL

ISO 9001:2008 Lead Auditor

HEALTHCARE

EXPERIENCE

Voster Consulting, Tampa, FL

Owner & President

Execute the design, development, implementation, certification audit and newly appointed management representative quality systems training for startup medical device manufacturers.

ISO 9001, ISO 13485, US FDA CGMP & 21 CFR 820 QSR, European Union MDD, and Health Canada CMDCAS compliant quality management systems.

Product safety testing, certification, and sterilization validation project management to Underwriter Laboratories (UL) & ISO specifications and guidelines.

Vascular Technologies, Inc., Tampa, FL

Regulatory Management Representative, Director of Production, Product Certification

Designed, implemented, certified and maintained the company's ISO 9001, 13485, US FDA CGMP & 21 CFR 820 QSR, CMDCAS, and EU MDD CE compliant quality management system. Responsible for carrying out all duties associated with the creation and maintenance of the quality management system, approximately five years, including certification and surveillance audits by the US FDA, DEKRA, and TUV SUD America as well as independent third party internal audits for system monitoring and maintenance.

Assisted top management on developing organization vision and mission statements to align short and long term company goals.

Managed product redesign and certification to world class standards, allowing product to be distributed Internationally while increasing the safety, accuracy and functionality of device.

Managed worldwide product line optimization and performance standardization. Reduced device production waste by 18% and per consumable production waste by 22% annually, improving efficiency and quality through Lean Six Sigma principles and practices (DMAIC).

Negotiated joint ventures with vendors to establish an innovative process utilizing injection molding technology to develop new market business and improved product quality, production efficiency, and overhead costs for various consumable manufacturing.

Created a teamwork & open-door environment conducive to positive dialogue across the organization. Personal efforts cited as driving force behind company's clear communication, expeditious conflict resolution and successful collaborative efforts. Large value created by combining diversity, communication, clear goals and objectives.

Managed TUV SUD electrical safety testing certification to UL 60601-1:2003 standards and obtained the CE Certificate of Conformity with European Directive through NEMKO, establishing the device as a world class product ready for International registration and product launch.

Negotiated International distribution contracts and led product registration projects in Canada, EU, South Korea, Japan, Mexico, China, South America, Russia, and India.

Streamlined/continuously improved company quality system through use of management reviews, document control processes, in-process check processes, traveling certificates of compliance (COC) ensuring manufacturing quality and standardization, and customer surveys/complaints by creating measurement systems for reporting to top management and providing simple solutions to complex problems.

Created/managed central company database to allow satellite, virtual office environments, and corporate headquarters the ability to access one source of always current information. Project enabled streamlined processes, increased efficiency and paperless audits.

REAL ESTATE

EXPERIENCE

Realty Options, Inc., New Port Richey, FL

Co-owner, Licensed Realtor(R), Operations Manager

Negotiate & manage contracts with engineers, contractors and other vendors.

Conduct feasibility studies on new residential projects for builders and investors.

Responsible for directing all accounting operations, reporting, audit and risk management activities.

Delegate responsibilities among team members for asset valuation, construction management, and property valuation.

Multi-million dollar sales producer of commercial, residential and high-end waterfront properties.

Created the industry standard in the tri-county area for 360 virtual tours; customized for Realtors(R), listings, & individuals for real estate and insurance requirements.

Assured Title Agency, Inc., New Port Richey, FL

Co-owner, Licensed Title Agent, Escrow Disbursement Manager, Operations Manager

Fulfilled broad range of HR, financial, and operational functions including:

Quarterly audits conducted by independent underwriter

Recruiting/training employees

Administering benefits

Overseeing disciplinary actions

Managing HR records

Financial accounting and escrow disbursement of up to $50mm; zero non-conformances or discrepancies

Document retention and electronic storage

Operational streamlining of employees and processes to eliminate reproduction and increase effectiveness.

Mortgage Today, Inc., New Port Richey, FL

Mortgage Reviews, Disbursement Manager, Operations Manager

Fulfilled all financial duties associated with receivables, disbursements, and operational responsibilities.

SKILL SETS:

Microsoft Office Outlook, Various Web Based Platforms

Microsoft Office - Access, Excel, PowerPoint, Word, Microsoft Sharepoint Online

Adobe Master Collection CS4 - Acrobat, Bridge, In-Design, PhotoShop, Distiller, SoundWave

Project/Product Management

Statistical Software

Minitab, Stat-Graphics

CERTIFICATIONS

DMAIC Six Sigma Black Belt (SSBB) at Villanova University

Lead Auditor ISO 13485:2003

Lead Auditor ISO 9001:2008

Realtor(R) - National & Florida Association of Realtors(R)

Private Pilot License - United States Department of Transportation

3rd Class Medical Certificate - Federal Aviation Administration

AFFILIATIONS

American Society for Quality "ASQ"

FDA Medical Device Industry Coalition "FMDIC"

International Standardization for Organization "ISO"

Aircraft Owners and Pilots Association "AOPA"

Cirrus Owners and Pilots Association "COPA"

REFERENCES

Available Upon Request

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