Quality & Regulatory Leadership Professional

PAMELA CHLEBEK

Neshkoro, WI *****

*******@*****.***

Cell: 847-***-****

EXECUTIVE SUMMARY

Quality/Manufacturing professional who creates strategic alliances with organization leaders to effectively align with and support key business initiatives. Builds and retains high performance teams by hiring, developing and motivating skilled professionals.

Client-focused and relationship-oriented management professional who has developed excellent market insight and the industry acumen necessary to guide businesses to success both domestically and internationally. SKILLS

● Six Sigma / Lean Manufacturing

● Project management

● Leadership/communication skills

● Business operations organization

● Customer-oriented

● Self-motivated

WORK HISTORY

RB Royal August 2023 – January 2025

A leading manufacturer of fluid movement tubing for the marine, automotive and heavy equipment industries.

Senior Quality Engineer

Updating the Quality requirements for the new ERP system

• Creating PFMEA, Flow Charts and Control Plans within the new system

• IMDS registration for the automotive sector of the business

• Prepared all PPAP documentation for customer requirements

• Conducted process capability studies, as required MedTorque, Inc. January 2019 – January 2023

A leading manufacturer of proprietary products and contract manufacturer of medical devices.

Director of Quality & Regulatory

● Responsible for Quality and Regulatory for 2 facilities, located in Kenosha, WI and Elmhurst, IL

● Total employees of 145 people.

4 Quality Engineers

1 Quality Supervisor

1 Quality Manager

14 Inspection Technicians

● Management Representative for the ISO 13485 registration

In 2021 lead the organization in changing our registration from a domestic company to a company recognized by the EU Community.

CAPA process for the company working with all levels of the organization, using the 5 why process and fish diagrams for root cause analysis

● Validation processes for machining process and special processes e.g. cleaning, heat treat, EDM, and passivation

● A member of Lean implementation team to gain velocity of strategically adding inspection to key areas during the production process

WEIMAN PRODUCTS, LLC September 2007 – December 2017 A leading manufacturer of FDA regulated medical products, disinfectants and cleaning solutions, distributed in US, Canada, Japan and China markets

Weiman is also a recognized leader in household specialty products for cleaning. Distributed through recognized companies, such as, Wal-Mart US and Central America, Lowes US and Mexico, Menards, Canadian Tire, Publics, and Target.

Compliance Director

June 2012 to Dec 2017

ACCOMPLISHMENTS:

● Expanded our current ISO 9001 registration to ISO 13485 registration. Responsibilities include – Management Representative to the FDA, CAPA, Internal Audits

● Responsible for all Regulatory Compliance including labeling, shipping and distribution to off-shore distribution.

● Responsible for process and line validations

Quality Assurance Director

September 2007 to June of 2012 / promoted to Compliance Director Through leadership of cross-functional teams developed and implemented

● Outsource Supplier Specifications by formalizing the information in a structured document, implementing a standardized lot coding system and compliance documentation to assure the products are produced to our specifications.

● Developed a Product History Record for non-regulated items and a Device History Records (DHR) for regulated items for the internal manufacturing personnel providing a concise document to record information to enhance the traceability of products produced to the component level.

● Through the development of the above document PHR / DHR the finished goods inspection was reduced from 4 inspectors to 1 inspector. Our internal rejects and customer quality was improved through this effort.

Prior Positions

JW PETERS, Burlington, WI

Quality/Operational Excellence Manager

PRECISION RESOURCE, Vernon Hills, IL

Quality Assurance Engineer

FOOTE JONES ILLINOIS GEAR, Chicago, IL

Divisional Material Manager

ARNOLD ENGINEERING, Marengo, Il

Manager, Technical Operations (Asst. Plant Manager) EDUCATION and TRAINING

COLUMBIA COLLEGE

Bachelor of Science Degree in Business Management

I started my college degree pursuit at the University of Nebraska in the Engineering department pursuing a degree in Industrial Engineering. I completed my degree as a Business major at Columbia College a few years later.

McHenry College – Completed APICS training with Certification – Inventory Management

Exolytic, Inc. – Completed ISO 19011:2002 Internal auditor training with certification

Six Sigma / Lean Manufacturing training - Green Belt Certification TUV - MDD to MDR transition June 2019

TUV - MDSAP Internal Auditor June 2019

● Salary History and references furnished upon request

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