Kelly S.

Okdie
ASQ CMQ/OE, CQE, CQA, CQPA, CSSGB; AAMI CQSM
www.linkedin.com/in/kellyokdie
Perrysburg, Ohio 43551

419.467.0681
KellySOkdie@yahoo.com

Quality / Engineering Operations Executive

Innovative executive leader and business partner offering a record of success leading quality initiatives combined with hands on
leadership that impacts the performance of an organization that demands exceptional quality, operations and profit growth. Set
short- and long-range strategic plans that drive performance. Respected mentor and team leader; build high performance and
collaborative teams that take accountability and tackle steep challenges. Recognized change agent that can lead operational
transformation and achieve business goals. Passion for delivering results; offer the highest level of professional work ethics and
business acumen.

Areas of Expertise
Problem Solving Methodologies Quality Assurance / Quality Engineering ISO 13485/9000 Auditing
Regulatory Compliance Supplier Assessment/Management Document Control Training
Customer Relations Strategic Planning & Execution Cost Containment Lean Principles Team Building CAPA
New Product Development & Launch Project Management Labor Relations Best-in-Class Performance Manufacturing
Budget Management Cross-Departmental Relations MS Office Suite MFG PRO (QAD) Safety

Certifications
ASQ Certified Manager of Quality & Organizational
ASQ Certified Quality Process Analyst (Certification No. 485)
Excellence (Certification No. 8397)
ASQ Certified Six Sigma Green Belt (Certification No. 12518)
ASQ Certified Quality Engineer (Certification No. 38175)
Certified ISO Lead Auditor, Vanguard Training (Serial No. 0509)
ASQ Certified Quality Auditor (Certification No. 25972)
Certified ISO 13485 Lead Auditor, CALISO (Certification No. 25199)
AAMI Certified Quality System Manager (Certification No. 468342)

Career Synopsis & Milestones

PRINCIPLE BUSINESS ENTERPRISES, INC.; Dunbridge, Ohio ...................................................... June 1999 February 2016
PBEs strength is in the design and development of high performance absorbent niche products.
Advanced to positions of increased leadership and oversight to include holding chairperson roles
Director, Quality Assurance & Regulatory Compliance (October 2013 February 2016)
Reporting to the CFO and VP of Finance, promoted to execute a Corporate Quality Program encompassing all departments from
Sales & Marketing through Warehouse & Logistics including achieving ISO 13485 compliance. Lead strategy and direction to
resolve quality issues surrounding raw materials, in-process materials and all finished products. Serve as a trusted liaison
between internal and external sales representatives, clinical quality assurance and production personnel. Initiate and direct
activities regarding customer visits and supplier audits. Work collaboratively with new product development and project teams
to ensure smooth and compliant launches. Conduct internal audits and external / supplier audits; manage company-wide
metrics development and reviews with the executive team. Facilitate Quality Assurance, Document / Records Control, and
Corrective / Preventive Action training sessions. Provide leadership to 10 quality hourly and salary professionals; serve as the
Technical Packaging Team Chairperson.

Teamed with the new Product Development / Project Team to launch two new products. Developed game plan that
supported release fall 2015.
Leading transition from a quality control model to a quality assurance program. Moving QC to the production floor.
Spearheading effort to utilize a budget for financial tracking and capital expenditure.
Created, implemented and project managed a full document control system including change control.
Established and Chair the Material Review Board (MRB) in order to address nonconforming product.

Quality Assurance Manager (March 2002 October 2013)

Selected to lead and coordinate plant-wide quality training programs for new employees and established employees, including
blind product inspections and SPC. Maintained quality standards, including Best in Class performance, in a rapidly expanding
organization that increased production by ~400% and product offerings by more than fifty different SKUs. Conducted internal
and external product and manufacturing line qualification trials. Oversaw 10 quality professionals.
Improved quality check efficiency & introduced objective guidelines for quality inspection criteria.
Computerized process characteristics for real-time availability.

Kelly S. Okdie
ASQ CMQ/OE, CQE, CQA, CQPA, CSSGB; AAMI CQSM
Technical Packaging Team Chairperson (November 2008 February 2016)
Requested to direct the interdepartmental team in design packaging for new products introduced to the marketplace.
Prioritized all packaging projects company-wide to meet inventory requirements, production needs and product availability.
Provided sizing requirements and dimensional analysis for all packaging materials. Communicated with packaging material
suppliers to ensure shipping requirements, production needs and cost models adherence.
Corporate Communication Team Chairperson (August 2011 September 2014)
While serving as the Quality Manager, led an eight-member interdepartmental team of salaried professionals to review
communication needs throughout the company. Recommended improvements to current systems and implemented new
communication programs. Conducted intra-company focus groups to determine type of communication required and the
effectiveness of efforts. Collaborated with leaders of various departments to meet communication goals.
Quality Assurance Technical Support Leader (June 1999 March 2002)
Recruited to supervise QA Laboratory Technicians, develop schedules, and manage the project management team. Provided
leadership to five hourly employees. Resolved product complaints including root cause analysis, tracking, and corrective action.
Initiated and maintained plant-wide specifications on all manufactured products and raw materials. Integrated all specification
and product structure information into the MFGPRO software program. Maintained MSDS information throughout the plant.
BAY WEST PAPER CORPORATION; Middletown, Ohio ................................................................... November 1994 June 1999
Leading specialty paper producer of fine color, commercial printing and customized industrial grades, as well as the innovation
leader in environmentally preferable towel & tissue products and dispensers. Now known as Wausau Paper.
Quality Engineer (February 1998 June 1999)
Promoted to direct and coordinate activities involved in maintaining an ISO 9001 Quality System, including functioning as the
Lead Auditor and Management Representative. Maintained mill-wide specifications on all grades of paper produced. Provided
problem solving analysis for quality issues surrounding finished product and machine operations. Tracked finished product
quality through statistical analysis methods. Trained hourly and salaried personnel in all aspects of quality compliance, ISO 9001
and statistical process control.

Recognized as one of two that led successful implementation and achievement of certification to ISO 9001.
Personally led efforts to maintain ISO 9001 certification for three (3) years.

Fiber Coordinator / Receiving Supervisor (March 1997 February 1998)

Deink Process Engineer (January 1997 March 1997)
Quality Assistant (January 1996 March 1997)
Process Engineer (November 1994 January 1996)

Education & Professional Development

Master of Science Quality Assurance Kennedy-Western University June 2006
Bachelor of Science Engineering Management Miami University May 1999
Bachelor of Science Paper Science and Engineering Miami University May 1994
Analytical Problem Solving, Cost of Quality and Statistical Process Control, FMEA & Root Cause Analysis
Train the Trainer for ISO Auditing Train the Trainer for Analytical Problem Solving
Statistical Process Control (SPC) ISO 9000 Internal Auditor ISO 9000/13485 Lead Auditor
Regulatory Affairs Certificate: Medical Devices (RAPS) FDA/GMP Quality System Requirements & Industry Practice

Professional Memberships
American Society for Quality (ASQ)
Association for the Advancement of Medical Instrumentation (AAMI)
Regulatory Affairs Professional Society (RAPS)
National Association for Continence (NAFC) and member of the Absorbent Task Force (ATF)
Engineering Technology Advisory Committee at Bowling Green State University