Quality Assurance Manager

CHRISTOPHER S. SLIMAK

**** ******* *****

McHenry, IL 60050

Home 815-***-****

Cell 734-***-****

e-mail ***********.******@*****.***

Career Objective

A Director level position in Quality Assurance in the Medical Device,

Biologic, or Pharmaceutical industries. A job focused on the continuous

improvement of quality systems, manufacturing processes, and product.

Work Experience

Baxter Healthcare Corporation - Round Lake, IL

Manager II, Quality Engineering Disposable SPO Quality Engineering

December 2009 - Present

Reporting to Senior Director, Director Quality Technology Sustaining

Product Organization (SPO)

Manage the activities and interfaces of the Global Access and Renal

Disposable Quality Engineering Department (16 FTE's and 10 contractors)

with responsibility for results in terms of product quality, performance

and safety. There are four (4) direct reports; two (2) Manager I, Quality

Engineering IV Sets and two (2) Manager I, Quality Engineering Renal PD and

HD Disposables. Responsibilities included, implement Quality System

procedures and manage compliance for the Access and Renal Disposable

products. Specifically, lead complaint investigations, own and approve

CAPA's and nonconformance's, lead the effort for Field Corrective Action

Assessments, complete monthly product quality trending, review and approve

design changes, lead the efforts for risk management, Core Team Members of

the DHF Remediation Team, and lead/support front room and back room

activities for audits and inspections. Lead Quality Initiatives and

identify and manage continuous improvement projects with the objective of

achieving quality, reliability and cost improvements. Develop Quality

Engineering functions capable of providing guidance and tools for problem

solving using appropriate quality tools. Identify, implement and report

Quality Metrics for the area of responsibility.

Terumo Cardiovascular Systems Corporation - Ann Arbor, MI

Director, Quality October 2008 -

November 2009

Reporting to Vice President Regulatory Management and Quality

Promoted to the position of Management Representative following an

extensive FDA inspection. There are eight (8) direct reports; three (3)

Business Unit Quality Chiefs, one (1) Quality System Chief, two (2) Product

Development QE Chiefs, and two (2) complaint system supervisors.

Participated in meetings with the FDA to discuss and resolve the findings

from the FDA Inspection. Developed and implemented the plan to address the

issues found by the FDA and address the systemic root causes of the issue.

The improvement included; 1) The implementation of a new CAPA System,

including software, 2) Implementation of a new internal audit system and

interaction with the new CAPA system, 3) creation of a system to address

off-the-shelf and custom software, 4) remedial actions to address issues in

the complaint and MDR process, 5) the overhaul of the non-conformance

system, 6) remedial action of the design control system, 7) remedial action

to address the document control and production change control processes,

and 8) significant reduction of open complaints, open non-conformance, and

open product investigations. Developed an internal training program to

educate operations on the FDA regulations and ISO requirements.

Director, Product Development Quality Engineering September

2006 - October 2008

Reporting to Vice President Regulatory Management and Quality

Created the Product Development Quality Engineering Department to deal with

quality issues coming from new product development. Started with three (3)

Quality Engineers and grew the department to seven (7) Quality Engineering

and one (1) Quality Technician. Part of a cross-functional team to

overhaul and implement a new Product Development Process. Implemented a

new risk management process in alignment with IS) 14971:2007 and created

risk management files for older product. Successful launch of two (2) new

electromechanical devices and three (3) new cannulae products

Becton Dickinson, Inc.

Quality Assurance Manager October 2005 -

August 2006

Reporting to Plant Manager

Responsible for the Quality System of a pharmaceutical component (Hypak

Sterile-Clean-ready to Fill syringes) manufacturing facility. Reporting

structure included four direct reports (Quality Engineering Coordinator,

Quality Systems Coordinator, Quality Control Coordinator and GMP Expert)

and 50 total associates in the Quality organization. The responsibilities

of the organization included conducting internal and supplier audits,

coordinating ISO 13485 and 15-20 customer audits a year, investigating

customer complaints and non-conforming product, managing the CAPA and

document management systems, incoming inspection, in-process inspection,

final inspection, coordinating the calibration process, leading management

reviews, trending of quality results, leading and assisting with process

validations, completing Six-Sigma and process improvements projects,

working directly with customers on issues and product questions. Key

projects completed - implementation of a new CAPA system, design and

implementation of a new root cause investigation module using the existing

SAP software, creation of an internal audit and supplier audit system,

enhancements of the Management Review Process, Implementation of the BD

World Wide Process Validation Tool Kit, the creation of a daily Material

Review Board, and working with Engineering, Production, and Logistics to

bring in three EtO sterilization Chambers and 15 other new pieces of

equipment to increase the capacity of the site and reduce cycle time.

Validation Manager April 2002 -

October 2005

Reporting to Director, Corporate Validation Services

Initiated and led the implementation of the BD Validation Initiative in the

Diagnostic, Ophthalmic, Discovery Labware, and Pharmaceutical Systems

Businesses. Mentored the Program Managers in the above-mentioned

businesses. Lead the updates, revisions, and implementation of the BD

Validation Toolkit revision 2.0. Trained BD sites around the World on the

BD Validation Toolkit. Led project teams to create and implement a World

Wide System for 21 CFR Part 11 and Design Control. Performed validations

at BD sites around the World. These validations included insert molding,

assembly, cleaning, filling, and equipment. Assessed quality systems

against 21 CFR Part 210, 211, and 820. Optimized and validated a cleaning

process (Black Belt Project). Mentored other Black Belts in their

projects.

Johnson & Johnson - DePuy, Inc.

Senior, Project Quality Engineer February 2001

- April 2002

Reporting to Manager, Quality Systems

Quality Engineer for the Custom Device and Orthobiologic departments.

Supported the manufacturing groups with process improvements and

validation/verification activities. Assist the Custom and Orthobiologic

departments with the design control activities associated with new and

existing products. Conducted design and process FMEA's for new product as

well as existing products. The day-to-day activities included reviewing

manufacturing processes, complaint investigation, nonconformance

investigation and disposition, initiate and review protocols, initiate and

review changes to procedures and work instructions, and develop and

implement new gauging. Assisted other departments with sample size

justification and statistical techniques.

Senior, Supplier Quality Engineer August 1999 -

February 2001

Reporting to Director, Supplier Quality Management

Assisted with the closure and transfer of the DePuy ACE facility to

Switzerland and Warsaw, IN. Managed approximately 80 suppliers,

manufacturing castings, packaging material, finished instruments, finished

implants, and providing packaging services. The day-to-day activities

included reviewing and disposition of non-conformances, issuing and

reviewing supplier corrective action requests, working with the suppliers

on process validations, working with the suppliers on improving their

internal quality systems, work with engineering and the supplier to improve

the product, and tracking and trending supplier performance. Worked on new

product launches in both the trauma and orthopedic business units.

Developed supplier quality management systems.

Johnson & Johnson, Inc. - Ethicon, Inc.

Raw Material Quality Assurance Supervisor October 1998

- August 1999

Reporting to Manager, Quality Technology

This position was run in concert with the Supplier Representative/Liaison

position. Supervise seven people across three different facilities.

Coordinate the day-to-day inspection of raw materials and validation

materials, for three manufacturing facilities. Increased the efficiency of

the lab and reduced the cycle time for incoming inspection of raw

materials. Implemented initiatives to reduce non-value added work.

Supplier Representative/Liaison September

1997- August 1999

Reporting to Manager, Quality Technology

A Quality Assurance position requiring direct communication with suppliers

to ensure compliance to the three phases of the Supplier Quality System

(SQS) process; Implementation, Certification, and Continuous Improvement.

Knowledge base to include an understanding of Ethicon's functional

departments - Purchasing, Quality Assurance, Development and Support,

Documentation Services, Developmental Groups, and Materials Management.

Qualified as an Ethicon, Inc. and Custom Kit/Sterilizer auditor. Perform

Supplier, Custom Kit, and Sterilization audits. Investigate and recommend

corrective actions to non-conformances related to SQS materials. Write and

run protocols for new suppliers. Conduct Process Excellence Initiatives

with suppliers, including Process Mapping, Cause & Effect Matrix, FMEA and

statistical analysis. Assist with FDA and ISO audits.

Johnson & Johnson, Inc. - Ortho Clinical Diagnostic Systems, Inc.

Associate Quality Engineer April 1997 -

September 1997

Reporting to Manager, Quality Engineering

Develops and executes manufacturing process validations, cleaning

validations, Steam-In-Place Qualifications, Autoclave Qualifications, and

performance qualifications. Performs and understands standard statistical

principles, theories, concepts, and techniques in evaluating manufacturing

process, sampling plans, and problems. Evaluation of critical process

characteristics. Assisted with pre-FDA audits. Developed and updated

manufacturing characteristics databases.

Assistant Technician September 1996 -

April 1997

Reporting to Manager, RHOGam Production

Performed all tasks related to protein fractionation, lyophilization, bulk

preparation, and sterile filtration, in the production of RhoGAM, a

parenteral. Strict adherence to cGMP's, SOP's, STP's, processing

specifications, and batch records. Perform sample titrations, reagent

preparation, and reagent addition. Assemble continuous flow centrifuges,

precipitation/collection tanks, mixers, sterile filtration housings, and

bulk vessels.

Education/Affiliations

BS, Biochemistry, May 1996

Benedictine University, Lisle, IL

MS, Quality Assurance/Regulatory Affairs, August 2003

Temple University, Philadelphia, PA

Member American Society of Quality, ASQ certified Biomedical Auditor

Member Regulatory Affairs Professional Society

Training/Skills

-6 Sigma/Process Excellence Training through Johnson & Johnson - Black Belt

-6 Sigma for Manufacturing Training through Becton-Dickinson - Black Belt

-Geometric, Dimensioning & Tolerancing, taught by Gary Griffith

-Kepner/Tragoe Problem Solving and Decision Making

-Design Control: Requirements and Industry Practice, AAMI

-GMP/QS Requirements & Industry Practice, AAMI

-Computer experience with Microsoft Office: Excel, Word, Power Point,

Access, Visio, and Microsoft Project. Trained in the use of Minitab for

Six-Sigma Projects and continuous improvement. Other - SAP, Lotus Notes,

Concerto Project Management, Sampling Plan Analyzer, several different

Document Management System, and Reliance EtQ Complaint and CAPA modules

Public Speaking

Lead Speaker for AdvaMed/MTLI. Conferences included Process Validation

(September 2003 and February 2004), Design Control (June 2004, October

2005, and October 2006), and Risk Management (October 2005 and October

2006). Speaker on Change Control for Medical Devices at International

Quality and Productivity Center Conference, December 2003.

References Available upon request.

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