Quality Assurance Manager

J effrey A. Weese

**** ***** ******, *****, ****, 44312

330-***-**** / ******@***.***

Quality Assurance Leader

Quali ty professional working for over 22 years in manufacturing and distribution.

E xtensive experience in Process Validation, Contract Manufacturing, Supplier

A uditing, and New Product In t roductions under FDA regulated processes.

Developed the Quality system for a distribution company – Vendor Managed

I nventory of MROP products – including defining Roles & Responsibili ties, defining

team objectives, and creating new positions within an ISO 2001:2008 registered

Quali ty Management System. Education: B.S. Mechanical Engineering, MBA with

concentration in Finance, and Project Management.

P ROFESSIONAL EXPER I E NCE

BARNES D ISTR IB U T IO N NORT H AMER ICA – C leveland, Ohio, 2008 –

P resent

Quali ty Manager

Quali ty Leader for 9 Distribution Centers in Canada and the United States with a

p roduct spend exceeding $150 million, including direct purchases from Asia.

M aintained ISO registration with no major corrective actions. Company

representative for all claims and quality complaints working with Corporate Legal,

Sales Representatives, customers, and suppliers.

• Led a Kaizen event in the largest DC reducing mismatched shipments by 95%

for large i tems.

• Improved and established ISO compliant processes to maintain ISO

registration including Management Review, Recall, and Customer

Complaints.

• Avoided over $1,000,000 in warranty claims working directly with the Sales

Representative, customer, and laboratory resources.

• Reduced network quality inspections by 70% by implementing a preliminary

i nspection prior to full network inspections.

• Reorganized the structure of the ISO document system and published a

Quali ty Manual in compliance with the standard and to satisfy customer

demands.

• Corporate Lead Auditor for a Business Unit Level Quality Risk Audit. Audits

performed at all 32 business unit sites in the U.S., Canada, England, France,

and China with accountability to the Business Unit President and

Leadership Team.

• Team leader for the qualification of customer specified product including

managing the t imeline, PPAP, and assuring inventory availabili ty.

• Team member on a DC Kaizen team that improved site packaging

t hroughput by 10%.

• Completed a Gap Analysis for the Quality function which resulted in the

c reation of roles in Regulatory and Inspection and prevention of Regulatory

action by a government agency.

• Quality Engineering Lead for all product investigations.

• Published Roles & Responsibili ties for Quality Assurance and a 5 year vision

s tatement. Rolled individual quality functions into a Quality Assurance

Department with three team members including a Program Manager

Continuous Improvement and Incoming Inspection Technician.

GOJO I N D USTR I ES, I NC. – Cuyahoga Falls, Ohio, 1992 – 2008

Quali ty Analyst I I I, 2002 – 2008

Manage the Process Validation Team for both packaging and chemical operations,

i ncluding four Engineers and two Technicians. Owner of the Contract

M anufacturing process including development of new products, evaluation of

suppliers, approval of specifications, coordination of supplier Process Validations,

and resolution of supplier deviations.

• Created Supplier Agreements for 20 Contract Manufacturers of FDA

regulated drug products and led negotiations between in house Counsel and

suppliers.

• Quality liaison with Pfizer, Inc., a customer who purchased a brand and kept

manufacturing in the facili ty. Addressed all validation questions, deviations,

and protocol changes as requested by the customer.

• Company representative with Canadian Agent representing GOJO with

Health Canada. No major findings were noted in their audit.

Quali ty Assurance Senior Group Leader, 1998 – 2002

Promoted to manage all incoming inspection – packaging and chemical – to support

an estimated $250 million sales pharmaceutical company including four Incoming

I nspection Technicians and four Packaging Audit Technicians and one off shift

Supervisor.

• Restructured the Packaging Audit function moving audit roles to Operations

and reducing Quality staff by 50% without affecting overall product quality.

• Team member on the Supplier Quality Management Team that developed the

supplier certification process.

Quali ty Technician, 1992 – 1998

Brought on board to support inspection of packaging components on 2 nd shift. Self

managed role growing from inspection to ownership of the Contract Manufacturing

p rocess.

• Developed and piloted the fi rst outsourced product leading to ownership of

t he Contract Manufacturing process.

• Reduced in process auditing of an assembly process from 100% to a control

sampling based on M I L-STD-105E or ANSI/ASQ Z1.4 reducing staffing needs

by four.

• Teamed with the Packaging Group to develop a specification template for all

Contract Manufacturing.

ED UCAT ION & CRED EN T IA LS

Project Management Certificate

Case Western Reserve University, Cleveland, Ohio, 2009

Master in Business Administration, Concentration in Finance

Case Western Reserve University, Cleveland, Ohio, 2002

Bachelor of Science in Mechanical Engineering

University of Akron, Akron, Ohio, 1992

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