Edward A. Panek

**** ******* ***** ****. *********, Ohio 44212

Telephone: 216-***-**** Email: acgcah@r.postjobfree.com

Looking for Medical Device Quality position involving FDA 510K regulated

products or quality position involving a technical product. I am looking

for a position where I can use my experience to make improvements and

produce an excellent product for the customer.

ISO 9001, 13485, 14001, 17025, FDA/ISO Processes, Six FDA 510K

16485, CFR 820 Development and Sigma, SPC - 5 years Validation/Verification -

Implementation -13 years 5 years

Service/Support Management - SAP, Navision, and 4th FMEA/HIPAA/Risk Analysis

Medical/Technical/Software/Electr Shift, JDE ERP experience - Processes - 5 years

onic - 7 years 15 years

Supplier Quality Verification and Knowledge Management/ Change Management

Audits - 5 years Technical & Sales Training - (ECR/ECO) for Medical

7 years Devices - 7 years

Field Sales/Quality Engineer

Spirol, Stow, Ohio

5/14-9/14

* Spirol wanted to grow sales in Midwest and I was hired to assist in

technical OEM sales by driving quality issues to resolution but budget

for this position was removed.

* Made technical sales calls to assist OEM customers in their purchasing

decisions from design stage through purchasing and quality. Mechanical

fastener technology.

General Manager/QMS Implementation

Filing Scale Company Twinsburg, Ohio

5/13- 2/14

* Hired to develop ISO 9001 QMS system in order to present company for

sale.

* Audited several suppliers to correct/ implement CPAR.

* Led team of 6 technicians, a local sales person, and internal

administrative staff.

* Developed from ground up ISO 9001 and 17025 standards to comply with

market requirements.

* Met regularly with end users to understand market needs from service

and sales perspective and developed tailored plans cooperatively.

* Audited suppliers for ISO 17025 and 9001 compliance.

* Passed without findings 2013 ISO 17025 and 9001 audits.

Quality Director, North America

10/12 -3/13

Facil Inc. Twinsburg, Ohio

FACIL is a full-service provider for fastening technologies.

* Led team of 10 international reports from technicians to engineers

responding in real time to production issues primarily for Daimler

Mercedes trucks.

* Modified quality program to be more in line with the standards of

competitors primarily by contrasting to the medical quality standard.

* Developed verification and validation test plans and documented

results using ISO 16485 and ASME, SAE standards.

Director of Technical Service/Quality

10/99 - 4/12

Codonics, Inc. Middleburg Heights, Ohio

Codonics designs, manufactures, sells, and supports medical imaging and

information management devices. I was promoted to develop our support

structure internationally supporting MDD in EU and Chinese FDA in

Shanghai.

* Led, developed and conducted both verification and validation testing

per FDA requirements for new product releases under 510K guidance for

products already in use by customers.

* Developed ISO 13485/9001 processes for service and support globally.

* Audited core suppliers with audit team to review quality issues.

* Audited overseas offices for 9001 compliance.

* Member of internal Quality Review Panel.

* Developed and Implemented corporate HIPAA compliance polices and

procedures.

* Responsible for leading, facilitating, training, and auditing our

platform of services to increase process productivity, effectiveness,

efficiency, and to improve the quality of Codonics' global processes.

* Integration of service into product development projects to be more

proactive and anticipatory for training, inventory management, and

troubleshooting client's issues.

* Used Lean methodologies and tools including Corrective Action,

FMEAs, 5S.

* Drove compliance for internal audits to FDA and the Codonics'

Quality System regarding process, procedures, work instructions,

and forms.

Engineering Product Manager - Consumables/Hardware/Software & Integration

10/03 -6/08

Codonics, Inc. Middleburg Heights, Ohio

* Developed ISO 13485 processes and QMS from ground up for my products.

* Adjusted products to be complaint with customer quality systems and

regulatory requirements. CE Mark, ROHS, CCC (China FDA), etc.

* Led teams responsible for new product releases and ongoing support to

current products including complete product life cycle.

* Led, developed, and conducted both verification and validation testing

per FDA requirements for new product releases under 510K guidance.

Technical Support Specialist

10/99-10/03

Codonics, Inc. Middleburg Heights, Ohio

* Primary support for technical issues involving Codonics' medical

equipment supporting end-users globally and over 50 OEMs

internationally including network, routers, hubs, switches, subnets,

gateways, UNIX, DICOM, HL7, and Microsoft troubleshooting experience.

* Provided detailed product training to employee groups and

distributors.

* Assisted in development of new software for tracking customer

complaints.

* Developed and conducted technical product training for external and

internal stake holders and delivered presentations globally to

audiences at all levels of technical expertise.

Service Manager

4/92-10/99

BBS Copier Company, Berea, Ohio

* Directed a team of 5 technicians servicing office equipment in the

greater Cleveland area.

* Directly handled difficult customer installations and troubleshooting.

* Managed inventory stocking levels and assisted in sales demonstrations

for new products

Electronics Technician, US Navy 10/85-10/91

USS Whipple (FF-1062) Pearl Harbor, Hawaii

* Primary responsible party for onboard surface-to-air RADAR systems.

* Hands on repair of electronics down to component level.

* Persian Gulf War Veteran.

* E-5 Rank with honorable discharge.

Education:

2010 Graduate University of Phoenix

Bachelor of Science Business Management

9/02-9/04 Cleveland State University, Cleveland, Ohio

Electrical Engineering

9/92-9/94 Cuyahoga Community College, Cleveland, Ohio

Core classes

10/85-6/86 United States Navy Electronics School, Chicago, Illinois

Radar and Electronic Technician

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