Quality Systems Management
Resume:
Kathleen A. James
********.*****@**.***
Auburn, AL 36832
CAREER SUMMARY
Professional with a career in the manufacturing industry for over 20 years, currently, as the Quality Systems Manager for an innovative injection molding manufacturer, who specializes in high-tech polymer packaging solutions. My 13+ years with the organization has led me to achieve a high level of success within each department, promoted within the company 5 times. My experiences range from quality, accounting, operations and business administration. I am a skilled auditor and trainer, with the ability to identify and assess changes to improve upon current processes. I have the ability to ascertain issues and develop solutions for organizational needs in order to be the most cost efficient, without compromising quality or commitments to customers. I have been involved in many Continuous Improvement Project Teams, DMAIC Teams, PFMEAs, and FMEAs. I have reduced inventory variances from over a 20% loss to less than 2% loss. I have developed performance and cost reporting metrics and developed weekly/monthly reports for analysis. I have designed, developed and implemented Access Databases for Quality Management Systems, including CAPAS, Complaints, Non-Conforming Products and Document and Data Control. I am a very talented, intelligent individual with a diversity of skillsets that make me a proven, invaluable asset to any organization.
Software Proficiencies
Proficient in Computer Technologies, variety of software with advanced skills specific to Microsoft Office – Outlook, Word, Excel, Access, PowerPoint, SharePoint, Visio, VBA, along with Minitab, Foxfire Report Writer, Adobe Pro. Experience with many different Enterprise systems, as well as Accounting Software such as Quickbooks, Mas90, ADP Processing and many others.
WORK EXPERIENCE
CSP Technologies, Auburn, AL July 2002 – Present
Quality Systems Manager November 2013
ISO 9001:2008 / ISO 13485 Certified Internal Auditor.
Team Leader for preparing organization for certification of ISO 13485.
Company representative for Customer Audits, ISO Registrars and/or Regulatory Agencies; provide, collect and present requested items for audits using discretionary skills to provide information and documentation limited only to pertinent, non-proprietary processes and information.
Responsible for all areas and management of QMS, not limited to Document Control, Customer Complaints, CAPAs, Internal Audits, Supplier Audits, Regulatory Compliance and all other aspects of the Quality Management System.
Key contact for all customer requests related to supplier qualifications.
Responsible for managing the Supplier Quality system.
Responsible for maintaining currents Supplier Scorecard records, Supplier Assessments and Regulatory Letters from suppliers for raw materials; responsible for completing Supplier Quality Self-assessments and Quality Questionnaires upon customer requests.
Development and implementation of new and improved processes for maintaining the organization’s Quality Management Systems.
Responsible for maintaining records of all correspondence for Customer Complaints and Correspondences, Internal Audits, Customer Audits, Supplier Audits, Supplier Corrective Actions, CAPAs and Non-Conformances.
Initiate and manage projects to improve the Quality Management System and other relevant process changes and improvements.
Develop more capability in the use of Six Sigma tools; DMAIC Team Projects; FMEAs;
Ensure all aspects of the business are compliant with the QMS and ISO 9001 requirements; Maintain, review and implement process changes according to customer requirements, along with International Standards, such as ISO 9001, 13485 and 14001; ensure company’s certification is valid to the most current standard.
Ensure status of all aspects of the QMS is communicated to management representatives and the systems that are in place are effective; Responsible for the data collection and reporting all of the performance metrics for Management Review.
Responsible for ensuring all associates have annual training to the cGMP.
Improve and maintain MSDS’s and ensure the accessibility to all associates.
Responsible for guidance and coaching the Quality Engineering Dept. in order to ensure completion of complaints, CAPAs, investigation of objective evidence and root cause analysis to respondents from initiation to completion; Responsible for ensuring the implementation of such actions are effective and cost-effective.
Maintain the QMS to be audit ready at any point.
Responsible for conducting Supplier Audits to ensure suppliers are compliant to quality standards, along with current ISO standards.
Operations Administrator/Data Analyst April 2008 – November 2013
Collect, report and analysis data in respect to meeting and exceeding company performance objectives and goals.
Analyze and explain daily and weekly scrap calculations.
Development of new operational initiatives and new reporting methods for analysis of raw data.
Auditor of weekly inventory/ production reporting procedures.
Lead Continuous Improvement initiatives on reducing scrap costs, labor costs and general spending.
Collect and report data trends and track statistical information, and follow up on areas that reported to be out of control, making recommendations for improvement.
Report and analyze performance metrics to Business Unit Managers Weekly
Production Administrator/Inventory Control Manager July 2002 – November 2013
Maintain and supervise daily machine production for four separate corporations.
Maintain perpetual inventory system through processing and reconciling daily production.
Prepare weekly inventory reports; identifying and explaining variances in production to upper management and corporate headquarters..
Calculate and analyze monthly labor costs; taking into account machine production costs
Analyze and explain variance in costs and production to upper management and corporate headquarters.
Prepare monthly financial statements and related account reconciliations.
Communicate proper procedures to machine operators.
Oversee annual audit of inventory counts and procedures.
Create and maintain reports to upper management.
Assistant Payroll Administrator July 2002 – February 2006
Craftmaster Printers, Inc., Opelika, AL April 2001-May 2002
Accounting Specialist
Perform accounts payable, accounts receivable and cash receipt functions
Analyze current and future cash flow needs by monitoring the available cash on hand, lines of credit, aged payables, works in process, job costing and payroll projected expenditures
Perform job costing analysis including evaluation of actual to budget job costs and communication of variances to sales team
Calculate and prepare payroll deductions including flexible spending deductions and other garnishments; prepare documents and coordinate payments to third parties
Assist in preparing monthly financial statements utilizing monthly general journal entries and reconciliation of general ledger accounts
Steck Manufacturing, Dayton, OH February 1999-March 2001
Bookkeeper / Office Manager
Facilitate customer inquiry resolution
Perform daily accounts payable, account receivable and cash receipts functions
Assist in preparing monthly financial statement utilizing monthly general journal entries
Assess and determine appropriate levels of petty cash on hand
Calculate and prepare payroll to include commission payment for sales representatives
Calculate employee deductions and garnishments from payroll; prepare documents and coordinate payment to third parties
Prepare payroll tax returns including the Federal 941, and State and Federal Unemployment
Reconcile tax returns to general ledger and payroll journal
Maintain perpetual inventory system through processing and reconciling daily production related to sales, purchases and returns.
Pohlman & Talmage, CPAs, Dayton, OH December 1997-October 1998
Account Technician
Assist in the preparation and distribution of US Partnership Return of Income for 1065 and related Schedule K-1’s for over 140 partnerships
Perform out-source payroll functions including Federal Tax withholding and payments for clients of Pohlman & Talmage
Maintain census database on weekly basis and present results on quarterly basis
Coordinate with outside Investment Management Companies to timely receive clients portfolio investments results
Perform typing, filing, copying and telephone back up duties as requested
Develop and maintain healthy client relations
BPC Manufacturing, Inc., Plymouth, IN September 1995-July 1997
Payroll Administrator
Oversee and maintain company employee database in accordance with
Personnel Laws
Perform initial review of applications and resumes to determine qualifications necessary for positions available
Assist in new hire orientation and education
Prepare weekly payroll for 150 hourly employees
Provide telephone back up on multi-line telephone and paging system
EDUCATION
Indiana University of South Bend, South Bend, IN
Business & Accounting
Jefferson State College, Birmingham, AL
Troy State University, Troy, AL
REFERENCES
Available upon Request
Contact this candidate