Edward Panek
Medical Device Quality / US Navy Veteran
- Role
- Vice President Quality and Regulatory at Blue Spark Technologies
- Location
- Cleveland, OH, US
- LinkedIn followers
- 500 followers
About Edward Panek
Quality and Regulatory Professional FDA 510(k) Processes ISO 13485…
Experience
Vice President Quality and Regulatory
Aug 2018 — Present · Cleveland/Akron, OH, US
Wearable/Smart Medical Device Regulatory and QualityMDSAP (FDA, Australia and Canada) 2024 to dateArtificial Intelligence Q-Sub and 510(k), De Novo Submission ExperienceLed upgrade from ISO 13485:2003 to ISO 13485:2016Led upgrade from ISO 9001:2008 to ISO 9001:2015Led Traditional FDA 510(k) submission to expand the product lineCertified ISO 13485:2016 lead auditor SAEImplemented numerous contract manufacturers and audited to verify ISO 13485 compliance.Obtained CE Mark MDD for class IIa medical deviceMDR phase IIn House manufacturing CE Mark and ISO 13485:2016 audit and approvalGDPR compliance implemented Spring 202021 CFR Part 11 Compliance Fall 2019RAPS Member and Moderator @ ElsmarCove Quality and Regulatory Forums https://elsmar.com/elsmarqualityforum/Featured Speaker American Society for Quality 2024 on FDA 510(k) Process
Education
US NAVY Radar School
Electrical and Electronics Engineering
University of Phoenix
Bachelor, Science Business Management
2008 — 2010
Cleveland State University
Electrical Engineering, EE
2002 — 2004
United States Navy Electronics School
Military Electronics, Radar Communications and Systems Technology
1985 — 1987
United states navy
Associate's degree, Radar Communications and Systems Technology
Skills
- Product Management
- Cross-Functional Team Leadership
- Engineering
- U.s. Food and Drug Administration (Fda)
- Negotiation
- Customer Service
- Strategic Planning
- Iso
- Business Process Improvement
- Fda
- Management
- Manufacturing
- Iso Standards
- Lean Manufacturing
- Knowledge Management
- Validation
- Global Services
- Leadership
- Iso 13485
- Process Improvement
- Product Development
- Change Management
- Team Leadership
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