Dana Lupo
Auburn
Summary
Accomplished Quality Manager with over 22 years of experience in developing and leading robust quality systems for highly regulated industries by determining risks and opportunities for improvement through gap analysis, internal, and supplier auditing. Proven track record of reducing Quality Costs, passing high-stakes Audits, and implementing data-driven Corrective and Preventive Actions. Advanced in experience with Root Cause Analysis (8D, Ishikawa, 3 x 5 Whys), and Data-Driven Decision-Making, supported by knowledge of GD&T, Calibration Systems, and application of Gage R&R.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Quality Manager
Refractron (Structural Filtration Ceramics)
Newark
04.2021 - 12.2023
- Led quality team operations, developed technical knowledge in ISO 9001, and risk-based QMS practices, including SWOT, PESTLE, FMEA, and Fault Charts.
- Sole representative to customers, suppliers, and third-party auditors.
- Passed six major audits and implemented corrective actions based on root cause analysis using 8D methodology, MRB, and subsequent ECR/Ns.
- Reduced the quality budget by a minimum of 15% year on year, reducing calibration costs and product failures.
- Created internal audit and supplier audit programs, and led management reviews.
Validation Engineer
Bristol Myers Squibb (SSI)
Syracuse
11.2020 - 04.2021
- Developed validation documentation for computerized lab instruments and non-computerized systems.
- Collaborated with SMEs for risk assessments, URS/FRS, and IQ/OQ/PQ.
- Ensured that data collection was accurate and conforming, and authorized the release of instruments.
Quality Systems Lead Engineer
Currier Plastics
Auburn
11.2017 - 03.2020
- Implemented ISO 13485 QMS from scratch; achieved accreditation in five months.
- Led seven customer audits (>$3B clients).
- Integrated phase-gate processes and FDA 21 CFR 820 compliance into NPD workflows.
- Authored and managed documentation, job descriptions, and KPIs.
- Organized management review and oversaw the audit process, all CAPAs, and customer complaints.
Failure Analysis, Validation Technician/ Calibration ESD, FMEA Coordinator
Marquardt Switches
Cazenovia
09.2012 - 11.2017
- Managed test systems and calibrated equipment, confidence samples, etc.
- Performed destructive and non-destructive testing on preproduction prototypes, collected all relevant data, and submitted it to the customer.
- Oversaw night quality plant production.
- Oversaw ESD testing, SOPs, and corrective and preventive actions.
- Moderated and authored all PFMEAs in the facility.
- Delivered over $130K in documented annual savings through quality investigations and process improvements.
QMS Coordinator
PPC (Metal Turning)
Syracuse
05.2012 - 09.2012
- Refurbished a derelict quality management system within eleven weeks.
- Closed out 44 corrective actions.
- Rewrote internal audit policies, and provided training to internal auditors.
- Completed the registration audit for a $1 billion multinational company.
PPAP Auditor
NSF
Remote
12.2011 - 05.2012
- Review PPAPs for non-OEM replacement parts for the American automotive industry, ensuring all eighteen elements were present and conforming, authorized and filled out.
Quality Manager
Weaver Machine & Tool
Auburn
03.2011 - 11.2011
- Built and led AS9100-compliant QMS from scratch; supported NADCAP compliance.
Failure Analysis, Calibration Coordinator, Off Shift Quality Lead
TRW
Auburn
09.2006 - 03.2009
Education
Bachelor’s -
Le Moyne College
Syracuse, NY01.2000
Associates -
Cayuga Community College
Auburn, NY01.1998
Skills
- Instruments: Oscilloscopes, Spectrum Analyzers, Wave Form Generators, Multimeters, CMM, Height, Plug, Ring, Block Form, Thread & Torque Gages, Various Calipers & Micrometers, Optical Comparators
- Software: Microsoft Office 365 Suite, Adobe Acrobat, Vizio, Access, SAP, Oracle based ERPs
Certification
- Lead Auditor ISO 9001: Eagle Group
- Lead Auditor ISO 13485: Velocity 360
- Supplier Auditor TS 16949: AIAG
- SPC, FMEA, APQP, PPAP, MSA Suite: AIAG
- Calibration Technician: ASQ
- Six Sigma Green Belt: TRW
- IPC 610, 620 J-Standard: TRW
Affiliations
ASQ Member - Knights of Columbus, 4th Degree - Ancient Order of the Hibernians - Knights of the Sacred Heart - St. Mary’s Choir, Auburn NY
References
References available upon request.
Timeline
Quality Manager
Refractron (Structural Filtration Ceramics)
04.2021 - 12.2023
Validation Engineer
Bristol Myers Squibb (SSI)
11.2020 - 04.2021
Quality Systems Lead Engineer
Currier Plastics
11.2017 - 03.2020
Failure Analysis, Validation Technician/ Calibration ESD, FMEA Coordinator
Marquardt Switches
09.2012 - 11.2017
QMS Coordinator
PPC (Metal Turning)
05.2012 - 09.2012
PPAP Auditor
NSF
12.2011 - 05.2012
Quality Manager
Weaver Machine & Tool
03.2011 - 11.2011
Failure Analysis, Calibration Coordinator, Off Shift Quality Lead
TRW
09.2006 - 03.2009
Bachelor’s -
Le Moyne College
Associates -
Cayuga Community College
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