Description
Degreed professional with 10+ years medical device quality engineering and managerial experience focused in manufacturing and R&D environments. Excellent leadership & interpersonal skills combined with expertise in team building, internal and external auditing, problem solving (RCA), facilitation, training, consulting, supplier partnering & supplier quality. & ACCOMPLISHMENTS: * ASQ Certified Biomedical Auditor & Certified Quality Engineer * Certified to FDA Quality System Regulation - GMP Requirements-AAMI Course ISO 13485 CFR 21, Part 820 * Design Assurance and Risk Management (ISO 14971) * Process Validation - IQ, OQ & PQ * GMP - Good Manufacturing Practices * CAPA and Complaint Processing * Directed over 12 companies to achieve ISO 9001 & ISO 13485 Certification * Certified to FDA Quality System Regulation - GMP Requirements-AAMI Course ISO 13485 CFR 21, Part 820 * CFR 21, Part 803 Medical Device Adverse Event Reporting * CFR 21, Part 806 Field Action Decisions * FDA 483 Response Experience * Orthopedic Implant Medical Device Experience * Former 3rd party ISO 9001 Lead Assessor - LRQA-Lloyds Register QA * Developed & implemented internal audit programs * Extensive facilitation experience with cross functional groups ASQ Certified Biomedical Auditor & Certified Quality Engineer * Certified to FDA Quality System Regulation - GMP Requirements-AAMI Course ISO 13485 CFR 21, Part 820 * Design Assurance and Risk Management (ISO 14971) * Process Validation - IQ, OQ & PQ * GMP - Good Manufacturing Practices * CAPA and Complaint Processing * Directed over 12 companies to achieve ISO 9001 & ISO 13485 Certification * Certified to FDA Quality System Regulation - GMP Requirements-AAMI Course ISO 13485 CFR 21, Part 820 * CFR 21, Part 803 Medical Device Adverse Event Reporting * CFR 21, Part 806 Field Action Decisions * FDA 483 Response Experience * Orthopedic Implant Medical Device Experience * Former 3rd party ISO 9001 Lead Assessor - LRQA-Lloyds Register QA * Developed & implemented internal audit programs * Extensive facilitation experience with cross functional groups
Work Experience
| COMPANY | POSITION HELD | DATES WORKED |
|---|---|---|
| Cardinal Health | Principal Risk Management Quality Engineer | 7/2018 - 2/2019 |
| Medical Leave | Zoll Medical/Bio Detek | 9/2017 - 3/2018 |
| Support Npi Projects | Lead Supplier Quality Engineer Employee | 6/2014 - 5/2015 |
| Electrochemsolutions | Contracting Assignments Capa & Internal Audit Manager / Mentor And Coach Chairperson | 2/2013 - 6/2014 |
| Validant Medical Device Consulting | Capa Remediation Engineer Contractor | 2/2013 - 2/2013 |
| Haemonetics | Supplier Quality Engineer Contractor | 11/2012 - 2/2013 |
| Boston Scientific | Quality Systems Manager Employee | 12/2010 - 11/2012 |
| Aspect Medical Systems/Covidien | Sr. Quality Assurance Engineer Employee | 3/2009 - 7/2010 |
| (Confidential) | Monthly And Quarterly Metrics | / - Present |
| (Confidential) | Initiate And Manage Scar's | / - Present |
| Maetrics Llc | Cqt Engineer/Consultant Stryker Orthopedics | / - 1/2009 |
Accomplishments
Highlights:
Job Skills
Keywords
