Dawn M. Skierski

oovzui@r.postjobfree.com **** Beach Road Canastota, NY 13032 315-***-****

Highlights of Qualifications

• Dual M.S. Engineering degrees

• Over ten years experience in all facets of quality, manufacturing and process engineering

• Managing or supervising personnel for over five years.

• Numerous accomplishments in improving quality, efficiency and costs

• Knowledgeable of regulations: GMP (drug and device), ISO, MDD, CMDR, Japan GMP, API, and Q7A

EXPERIENCE:

CONMED Corporation, Utica, NY. Quality Systems Engineer 11/10 – Current

• Manage the Audit Program to include, but not limited to, FDA Inspections, TUV Audits, DEKRA/KEMA Audits, Customer Audits, Corporate Audits and Internal Audits. Key contact during on-site audits, response plans and follow-up.

• Provide data analysis to management for monthly metrics, Analysis of Data Meetings and Management Reviews.

• Implemented TrackWise for maintaining Audit System. Before TrackWise, established audit tracking spreadsheets to communicate finding status with responsible person and management.

• Developing Audit program, new audit schedule, procedure updates, tracking sheets, internal audit program training.

• Supported Corporate Audit Program in auditing sister facility in Chihuahua, Mexico.

Complaint Handling Manager 10/08 – 11/10

• Manage the Customer Complaint Department of 1 MDR Specialist, 3 Complaint Handlers, 4 Quality Engineers, and 3 Temps. Increased department output, without increasing head count.

• Lead reduction efforts in order to reduced Complaint Backlog on average 85-95%. Maintaining at 75-90% without additional resources.

• Opened up Feedback side of TrackWise database to track Service, Customer Feedback, Incoming Inspection Rejections, etc. Implemented preliminary evaluations to rationalize no investigations.

• Continue to work with sister divisions to streamline complaint system/process.

• Responsible for Complaint, CAPA, and MDR Reporting of all divisions for Management.

• On Corporate Team to implement eMDR filing.

Quality Engineering Manager of Manufacturing Support 3/08 – 10/08

• Manage the Quality Engineering Department which included supervising 5 Quality Engineers and 2 Technicians.

• Responsible for supplying day-to-day manufacturing support for validations/qualifications, line down investigations, NCMR investigations, etc.

• Also responsible for supplying support to other Quality Systems, including complaint investigations, CAPA, Kaizens, etc.

• Key player in implementing Quality System for incorporating Mexican and distribution facilities into NY Quality System and procedures.

• Supported FDA, TUV and other audits.

Quality Engineer III 10/07 – 03/08

• Supported acquisition of new products. Reviewed Device History File for gaps.

• Responsible for customer complaint investigations, quality engineering support for product lines, etc.

• Participated on 2 Kaizen events.

Covidien (formerly Tyco Healthcare) 2/02 – 10/07

Kendall, Oriskany Falls, NY. Quality Engineer

• Supervised up to 13 technicians and inspectors for the Quality Assurance Department (Chemistry, Instrumentation and Receiving Labs, as well as, Document Control).

• ISO 13485 Lead Auditor, Internal Quality Systems Auditor and Supplier Auditor.

• Managed Quality Systems (complaints, non-conformances, audits, CAPA, training, metrics etc).

• Deputy Management Representative, during FDA, Compliance, and Corporate audits.

• Project Leader for Compliance Wire (training), Agile (documentation) and Re-branding efforts.

• Worked on projects to optimize testing and systems for Black Belt certification and Lean initiatives.

• Plant Quality Trainer for compliance (GMP, Failure Investigation, and FDA Readiness).

Mallinckrodt Baker Inc., Phillipsburg, NJ. Process Engineer

• Lead process and cleaning validation efforts.

• Provide GMP training for operators and help manage GMP efforts within the business.

• Supervised up to 34 personnel during weekend coverage and as needed to cover supervisor training and vacations. Prioritize manufacturing needs. Assist in training of new supervisors and engineers.

Mallinckrodt, Maryland Heights, MO. CAP Engineer

• Maintained Corrective Action Program. Provided monthly summaries, trending/tracking, and analysis to supervisors and managers. Designed new database to be operated by all employees.

• Completed Six Sigma Black Belt training in August ’02. Lead team through the six sigma tools to increase yield in the Cold Kit Products. Identified $100,000 in savings.

• Facilitated and participated in Lean and 5S events.

New Venture Gear Inc., East Syracuse, NY. Graduate Internship 5/99 – 5/01

• Maintained Machine-Down Database that 4 Managers, 2 Planners, and 25 Supervisors used on a daily basis to track the status of 668 machines. Analyzed for improvement opportunities.

• Designed and documented Capacity Flow Charts, Machine Efficiency and Manpower Spreadsheets, based from production numbers and scheduled hours.

• Maintained a scrap database and OME spreadsheet that charted on average $250,000 in scrap and $4,000,000 in OME costs (revolving 12-month period) for one division. Support management in analyzing charts to highlight and plan for improvement and cost reductions.

New Holland Inc., New Holland, PA. Project Analyst / Manufacturing Engineer 9/97 – 5/99

International Graduate Rotational Program.

• Training Department in New Holland, PA. Developed “Competitive Specs” and “Tooth & Nail Comparisons” of our tractors and hay tools for dealer training manuals. Instructor and Event Coordinator at the Spring Training for U.S. and Canadian dealers.

• Marketing Plans Department in New Holland, PA. Designed a process to verify CBU budgets, reducing the number of analyzing hours per year from two weeks to 3 days.

• Quality Department in Basildon, England. Researched Basildon’s history with the dealers, customers, suppliers, and in-house quality issues to draw conclusions of faulty remote valves. Implemented new processes and procedures.

• Machine Shop and the Press & Shear Shop in New Holland, PA. Conducted cost analysis of improving and computerizing Standards Sheets. Analyzed and implemented improvements to Press & Shear tooling inventory system, for usage and safety. Supervisor of 28 individuals as needed.

TRW Inc., Farmington Hills, MI. Manufacturing Engineer, Co-op(10/95-9/96) 10/95-9/97

• Coordinated manufacturing activities and Process Sign-offs to launch electronic switch programs for Chrysler, Ford, and GM, at supplier and production facilities (Michigan, Canada, and Mexico). Successfully achieved on time / within budget product launches.

• Documented the process of assembly lines/testers, including FMEA, flow charts, control plans.

• Conducted production and design validation builds: time studies, debugging, mistake-proofing and implement changes to the line.

• One of 27 engineers involved in the 1997 FIRST Competition (For Inspiration and Recognition of Science and Technology) teaching high school students about engineering.

EDUCATION:

Syracuse University, Syracuse, NY. 5/99 – 5/01

Completed dual Master of Science degrees, Engineering Management and Manufacturing Engineering. Part-time internship with New Venture Gear of Syracuse, NY. GPA - 3.7.

GMI Engineering & Management Institute, Flint, MI. 9/91 - 12/96

Received a Bachelor of Science in Industrial Engineering, with a thesis “Improving TRW’s New Switch Product Launch Process.” Mentored incoming freshman students. Co-op experiences include:

TRW Inc., Farmington Hills, MI. 10/95-9/96

• Redesigned the Switch Group’s Quote Package Process (my thesis). Supported the other engineers with a number of Process Sign-offs and product launches.

United Parcel Service, Buffalo, NY. 11/93 – 9/95

• Designed an Air Shuttle Plan for the Western N. Y. District (saving $100,000/year). Reorganized projects for efficiency: Hub small sort, letter center driver routes, and the feeder drivers (savings of $60,000 per trailer, yielding $300,000 per year and doubled trailer utilization).

AlliedSignal Bendix, Gallatin, TN. 10/92 – 7/93

• Established Work Standards and implemented Visual Factory for the new Aluminum Master Cylinder Department.

SPECIAL TRAINING:

• Regulations: AAMI’s FDA Quality System Regulation Training (QSR), US FDA cGMP Compliance Audits – Raising the Bar, Corrective and Preventative Actions, Conducting Successful Product Complaint Investigations, Effective Annual US FDA cGMP Training, New Medical Device Vigilance Guidelines, Complaint Handling in Compliance with FDA and ISO Regulations, ISO 9001:2000 36 hour Lead Auditor with Medical Device ISO 13485 Focus, and Complying with cGMP and GMP Requirements – Advanced Level, Active Pharmaceutical Ingredients Production

• Supervisor/Leadership: Supervisor/Leadership Training, Coaching Skills for Supervisors, Giombetti Leadership, Supervisory Leadership, Situational Self Leadership, and Leadership through Total Quality (TQM)

• Root Cause Analysis: Kepner-Tregoe Problem Analysis, Root Cause Analysis-Starting at the Beginning, and Root Cause/Incident Investigation

• Six Sigma/Lean: Six Sigma Black Belt (trained worked towards certification), Lean, and 5S

• Other: First Responder/CPR, Statistical Process Control (SPC), Introduction to Visual Basic Programming, and Value Diversity

REFERENCES AVAILABLE UPON REQUEST

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