Manager Quality Assurance Resume Project Management - Hire IT People

SUMMARY

Medical Device ISO 13485, CFR Title 21 Part 820, Tissue regulations, Part 1270/1271, Risk ISO 14971, ISO9001.
Led a team of engineers through New Product Development(NPD) under FDA 21 Part 820 for blood pressure monitors as well as technical review and approvals.
IPC - 610 certification/ 2010, IPC J-STD-001/ hands-on ability in SMT, PTH, materials in the manufacture of electronic circuit boards
Pharmaceuticals/OTC/Food Grade Plastics Requirements; PMAs, 510Ks(per FDA Art.21 820), aseptic filling (Sanofi/B&L), plastics-medical grade cannulas for delivery systems of pharmaceuticals with B&L, tubing for Baxter’s Home choice, Smith & Nephew’s silicon tubing for Negative Pressure Wound Care products and Lintavec orthopedics for material investigations and troubleshooting.
Certification of cleanrooms for B&L, Artemis Plastics for Validation review
Aerospace (commercial liners and Fighter aircraft DOD)
Munitions design for tank and aircraft(GE/General Defense/Olin Defense)
NAVSEA Nuclear Valves(White Consolidated)
ASME Section VIII Pressure Vessel codes GE turbines (Siemens-GE)
Team Building (Bausch & Lomb, Confidential, Baxter, CAE)
Regulatory Compliance (510K team (FDA (820)), complaint trending, CAPA systems creation)
Professional Recruitment Agency Owner specializing in technical fields; engineering and IT
Project Management
Lean Manufacturing
Facilities Management
Systems Engineering R&D
Total Quality Management/Quality Management System
Global Relationship Building
Process Improvement and validations

PROFESSIONAL EXPERIENCE

Confidential

Project Management

Responsibilities:

Orchestrated and validated a centralized documentation system using Oracle/Agile to reduce Confidential ’s required procedures across Mexico, UK, and Florida sites 50%.
Led ECAD S/W tool replacement/update initiatives, identifying low cost vendors and completing initiatives on time and $20K under budget..
Directed manufacturing, quality, compliance, and regulatory projects to recover Baxter Healthcare from a failed 2004 FDA audit. Built a readiness team and established inter-departmental relationships to improve product design and development procedures, delivering presentations to corporate management and the FDA in the first and second quarters of 2007 with favorable results.
Restructured quality system procedures in compliance with ISO13485 and QSR(FDA) requirements.
Built relationships with BSI to secure the CE mark for a majority of GE product lines. under ISO13485 requirements.

PROFESSIONAL EXPERIENCE

Manager Quality Assurance

Confidential -Crystal River, Florida

Responsibilities:

IT Solutions(Jabil IT consultant (Sept 2014-Feb 2015) Tampa, FL Validating the doc. System from Agile to SAP (Sept 2014-Feb. 2015)
Ind. Contract Engineering-Sr. Quality Engineer/Operations Engineer-RCA Associates (Aug 2012-Dec 2012) Tampa, FL, but travelled extensively
Ind. Contract Engineering-Advanced Manufacturing Engineering - Sparton Electronics (2012)-Brooksville, Florida
Ind. Contract Engineering-Sr. Quality Software Engineer-CAE Inc. (2011-2012)-Tampa, Florida
Contractor-Sr. QE-Regulatory Compliance Associates, Inc. Mitigation of a failed design requirement. Re-wrote the quality manual and validated manufacturing processes and procedres that failed during the audit with the FD.(2010).-Largo, Florida/Round Lake, IL
Contract Senior Quality Engineer-Smith & Nephew (2008-2009) St. Pete, Florida
Ind. Contract Senior Quality Engineer/Quality Analyst-Jabil Circuit (2007)-Tampa, Florida .

Manager of Engineering Services

Confidential - Tampa, Florida

Responsibilities:

Promoted from senior quality/systems development engineer to direct teams of up to 15 members, including technical writers, engineers, and technical assistants.
Led the NPI(NPD) team for design of blood pressure monitors and cuffs Created the DHF and the DMR per FDA(820) and ISO 9000(ISO13485).
Validated and then managed the conversion of Confidential ’s documentation and ECAD applications from a generic system to Agile/Oracle and PADS/VeriBest.
Created Post Market Surveillance Plan.
510K - contributed
Team effort from QA and Engineering to write and perform the IQ, OQ and PQ validations on equipment and site changes, specifically the Getinge sterilizer under FDA CFR21 Part. 820 & ISO 9000.
Project manager on a new plastics delivery feature for Bausch & Lomb Surgical’s ophthalmic drug/device, Ocucoat, amplifying product sales from $600K to $1.5M in the first year while minimizing customer complaints. Customers were surgeons worldwide.

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