Working on remediation projects that the company has been hired to complete.

Served as the project leader on a major packaging design change for all packaging content at the Zimmer Biomet New Jersey location. Wrote and executed IQ’s, OQ’s and PQ’s for sealers and tooling. Developed and wrote ATMV and VTMV for the new on-site packaging testing lab at TMT. Developed new requirements that required new suppliers be add to the ASL. Worked with supplier quality to on-board new suppliers and assisted on onsite supplier audits. Wrote and executed DOE’s for new process development and new validations. Work with current equipment providers on new ordered sealers. Documented and revised old procedures to meet new current requirements. Documented protocols for package material testing. Was working towards bringing the package and the supporting documentation up to meet new ISO 11607 and EUMDR requirements and new class III regulatory submissions to domestic and 3rd party CE registrar. Over new Clean room changes to add new sealers and room configuration changes to improve work process flow.

Perform packaging validations and document equipment requirements. Author IQ, OQ and PQ documentation. Participated on team execution of IQ’s, OQ’s, and PQ’s documenting results and submissions of record to Document Control. Document equipment specification, URS, equipment and package design specifications. DOE’s, TMV's , Preventative Maintenance and Calibration documents. Work with packaging lab to improve test procedures, method sample handling. Update print information and many other internally required documentation.Perform material studies on supplier material using Digital Scanning Calorimetry (DSC) Investigation of sampling failures for material related issues. Work with management on plans for replacement materials and packaging equipment. As well as new packaging methods.

Working with New Product Development and Manufacturing on remediation of validations. Writing, executing, and testing Operational Qualification (OQ), Process Qualification (PQ) documentation on Form Fill Seal packaging lines, Doboy pouch sealing equipment. Worked with sourcing group on material consolidation for the sterile packaging product group. Wrote and execute test methods for new testing as well as tests for Tyvek replacement material.

Member of project Trident Production &Process Control work stream. Performed detailed validation activities to meet customer required,FDA and ISO 11607 medical packaging validation requirements. Authored and executed required documentation for TMV, DOE’s, IQ’s, OQ’s and PQ’s on various packaging sealing equipment platforms such as Belco, Atlas and Multivac Nitrogen Backfill tray and vacuum pouch sealers. Project leader for the new packaging lab,directed the installation of the required utilities and facility structures. Oversaw the move of the equipment and installation, direct personnel on the execution of the required EQ’s, TMV’s, to ensure no time lose while supporting all project Trident validation activities being completed. Executed various DOE’s to establish new or support changing sealing process parameter of the sterile package system. Supported Package Development on various projects for product/packaging redesigns, required testing for design, transit and chemical compatibility testing. Helped support other Zimmer manufacturing locations to assist with packaging validation and equipment validations.

Worked for the Global Remediation Quality group for their Risk Management Quality group. Developing, documenting PFMEA's for Screw and Nail Manufacturing lines and Supplier Distribution to meet new risk management policy and practices. Worked on teams on internal DFMEA’s and PFMEA’s, and with external suppliers on their risk management documentation to support the product of Depuy-Synthes.

Worked for the Package Development department performing required investigation of historical validation activities as to meeting current medical packaging validation requirements. Authored and executed required documentation for TMV, DOE’s, IQ’s, OQ’s and PQ’s on various packaging sealing equipment platforms such as Belco, Atlas and Multivac as well as company designed platforms to meet ISO and current FDA validation documentation requirements. Worked on various projects for product/packaging redesigns, required testing for design, transit and chemical compatibility testing. CAPA as a Team Leader leading teams to collect and analyze quality data to identify existing and potential quality system problems and verify and validate corrective and preventative actions prior to implementation and verification of the effectiveness of those actions.

Develop and draft PFMEA’s to support the APQP product development and manufacturing processes.Input and support to the DFMEA process based upon the PFMEA development. Develop and document the Master Validation plan requirements for the current project and all supporting activities. Perform the validation investigating and documenting for equipment requirementsAuthor needed IQ, OQ and PQ equipment qualifications documents. Document equipment specification, equipment design specifications, and equipment qualificationsDocument TMV and SMV validation documents and worksheets Write equipment and processes DOE’s, Preventative Maintenance and Calibration documents Update print information for needed information additions and changes and many other internally required documentation and forms needed to submit to the Document Control Department as per St Jude Medical AFD Quality Manual and Policies. Participated on team execution of the IQ’s, OQ’s, document the results as evidence of completion and re-submission to Document Control.

Directed the daily operations of the quality department and Quality Engineers over saw incoming and outgoing inspection operations and reporting. Perform problem resolution and process improvement relating to defective product, working directly with manufacturing engineering, quality engineering, purchasing. Coached personnel in the use of new equipment calibration, test and measurement requirements. Manage the documentation control and records company wide, calibration and training departments. Responsible for planning, conducting and leading ISO required internal audits and supplier audits.

Directed the daily quality operations for a contract electronics circuit board manufacturer. Responsible for planning, conducting and leading ISO required internal audits and supplier audits. Manage the documentation control and records company wide, calibration and training departments. Perform problem resolution and process improvement relating to defective product, working directly with engineering, suppliers, and purchasing. Collaborated on improving supplier to customer relationship for key circuit board suppliers. Lead the quality team on the investigation, purchase and launch of new quality management system software to improve document control, nonconformance and corrective action reporting and the daily manufacturing process performance reports. Served as the company's ISO Management Representative. Drafted the level 1 quality manual for ISO 13485 medical standards, and developed level 2 and 3 procedures and work instruction.

Consolidated the various quality functions into a single department for a custom powder coater. Directed technicians on the daily wash stages titrations to ensure proper adhesion. Designed the receiving inspection and certification analysis of the chemicals and coating powders received daily. Performed the ISO required audits. Served as the company's quality liaison between key customer accounts. Collaborated with Engineer on many cost and process improvements. Site lead on the improvement project of the specialized powder coating line for powder coating plastics for a major office furniture manufacturer. Directed daily production and inspections, coached quality team members on various lean and quality improvement techniques.

Provide 3rd party internal auditing of the Magna Donnelly Quality/Business Management System to ensure 3rd party certification and to assist with the solid resolutions and effective implementation of corrective actions. To provide an outside perspective on how effective the quality system is. Assisting with the training of quality principles and processes to various level of management.

Directed a quality department for a custom blow molder of plastic products. Responsible for conducting required ISO internal audits. Manage the documentation control and records company wide. Perform problem resolution and process improvement relating to defective product, working directly with engineering, suppliers, and purchasing. Directed personnel in equipment calibration, test and measurement requirements. Improved the customer interface process for the supplier to customer relationship and perform supplier audits and supplier quality. Successful in achieving ISO: 9001: 2000 registrations at all 4 facilities within 1 year to maintain customer base and increase sales potential. Developed supplier evaluation program with purchasing, production control to help in the development of supplier quality. Project liaison between Delphi on quality or engineering related issues during an 11 tool transfer from another location. Resulting in no lost or down time due to quality related issues.Project leader for inventory management bar-coded labeling system to reduce on-hand inventory by 3 days and cost saving of $ 500.000.00 and no-miss labels to automotive customers.

Quality Team LeaderDirected and lead QS9000 certification project, Management Representative. Depot Repair Operations Manager Turned a small battery tester repair process into a 1.5 million dollar a year repair center of all SPX handheld or ship-able product lines.Technical Support SpecialistAuthored technical and engineering documentation for US based outside service support personnel.Regional Service Manager (Bear Automotive, an SPX Company)Direct a staff of 8 field service technicians across 4 states.Area Sales Representative (Bear Automotive, an SPX Company)