F. Joseph Wesling II has over 30 years of experience in quality assurance roles, primarily in the medical device industry. He currently works as a QA Leader at GE Healthcare, where his responsibilities include overseeing quality programs for refurbishing medical imaging equipment, auditing supplier sites, and training employees. Previously, he held supplier quality and quality control management roles at GE Healthcare and IMC Corporation, and started his career in quality assurance roles at Tyco Healthcare.
1. F. Joseph Wesling II
24 Laurel Valley Drive E-mail: fjoewes@gmail.com
Brownsburg, IN 46112 Phone: (317)752-3613
PROFESSIONAL SUMMARY
Strong QA professional with extensive FDA GMP, medical device, quality management system, auditing, regulatory,
and process development skills. Current responsibilities require utilization of Design Controls expertise in support of
Remanufacturing/Refurbishing programs for medical imaging equipment. Other responsibilities: Audit Leader for three
sites, utilizes metrics/reporting to drive on-time employee training, leads cross-functional Material Review Board in
review and disposition of potential non-conforming material and site QA Leader for internal supplier qualification and
relationships. Previous experience includes supplier auditing and supplier development with a goal of high quality, on-
time delivery and continuous improvement. In addition, 8 years of supervisory experience leading metrology and
calibration technicians.
PROFESSIONAL EXPERIENCE
GE Healthcare, Waukesha, WI & Noblesville, IN 2007-Present
QA Leader (September 2009-Present)
• Design Controls Program Quality Representative – Global QA leader for programs which develop processes
for refurbishment and remanufacturing used medical imaging equipment. Modalities include Ultrasound, CT,
MR, X-ray and Nuclear Medicine
• QA representative for UDI/Product Controllership implementation program for remanufactured ultrasound
equipment
• QA leader supporting production transfers
• QA oversight of engineering change control board
• Audit Program Leader for 3 GEHC Global Services sites
• Qualified Lead Auditor supporting GEHC Global Services
• Training Leader – Responsible for employee training process. Assign then drives on-time completion for global
team
• Analyze QMS changes and drive implementation on the site level
• CAPA owner and investigator
• Leads cross-functional MRB team
• Leads site Supplier Quality program
Supplier Quality Lead Engineer (October 2007-September 2009
• Project Manager for retrospective qualification of 300 suppliers at GEHC Canada site
• Managed over 400 suppliers for GEHC Canada and GEHC HCIT businesses
• Led Strategic Supplier Development
• Partnered with sourcing in quarterly supplier reviews
• Achieved GEHC Qualified Supplier Auditor and ISO17025 Auditor (Calibration)
• Developed supplier metrics for multiple sites
• Contributed to QMS development as Purchasing Controls Change Board member
IMC Corporation, Beech Grove, IN 2003-2007
Quality Control Manager (January 2003-October 2007)
2. • ISO 9001:2000 Management Representative. Sheet metal fabrication and machining
• Site CAPA Leader
• Site Audit Leader
• Supervised Quality Inspectors
• Led plant wide Lean Manufacturing program
• Led Site EHS/OSHA Safety Program
• Site QA contact for GE Appliance. IMC is a supplier of high appearance stainless steel and powder coated
dishwasher doors
• Site SME for GE Appliance Perceptive Quality and Workmanship Standards
Tyco Healthcare, Plainfield, IN 1985-2003
Tyco Healthcare was formerly known as Puritan-Bennett, Nellcor and Mallinckrodt
Supplier Quality Engineer (January 2001–January 2003)
• Led Supplier qualification. Maintained the site ASL
• Performed Supplier audits and led supplier development process
• Receiving Inspection Manager – Supervised 4 QA Techs
• Calibration Lab Manager – Supervised 2 Calibration Techs
• Site CAPA Leader
• Led Internal Audit program
• Coordinated external audit/inspection (e.g. FDA, TUV, ISO)
• Engineering change control
• Trained in Lean/Kaizen techniques
Process Quality Engineer (August 2000-January 2001)
• Partnered with manufacturing engineers in process improvement for fabrication, welding, assembly and test of
cryogenic oxygen delivery devices
• CAPA Leader
• Internal auditor
• Engineering change coordinator
Quality Assurance Analyst (April1985-August 2000)
• Established and managed the site calibration lab. Responsible for calibration of more than 2000 pressure, flow,
material test and dimensional instruments
• CAPA Leader
• Internal auditor
• Engineering change coordinator
EDUCATION
B.S. Management Cum Laude), December 2002
Indiana Wesleyan University - Marion, IN
ADDITIONAL EXPERIENCE
ASQ Inspection Division (Chair) 2015 – Present
ASQ Certification Board (Chair, CQI Exam) 2014 – Present
Wolfe & Swickard Machine (Quality Assurance Inspector) 1984 – 1985
Union Carbide Corporation (Quality Assurance Inspector) 1974 – 1984
TRAINING AND CERTIFICATIONS
GEHC Project Management Training; GEHC Six Sigma Green Belt Training; Tyco Healthcare Lean/Kaizen Training;
ISO Lead Auditor with Medical Device Focus (cert #Q17349); ASQ Certified Quality Auditor (Cert #19559); Certified
Quality Process Analyst (Cert #9); Certified Quality Technician (Cert #13385); Certified Quality Inspector (Cert
#9538); membership in AAMI and ASQ