PROFESSIONAL EXPERIENCE

Confidential, San Jose, CA

Senior Quality Engineer

Responsibilities:

• Leading effort to implement new corporate wide supplier selection and management process utilizing CATSWeb software tool.
• Managing ongoing supplier qualification audits in compliance with QSRs.
• Conducting HHE analysis to mitigate risks associated with safety testing for cardiopulmonary equipment.
• Implementing new internal audit program utilizing Trackwise software management tool.

Confidential, Wilsonville, OR

Supplier Quality Engineer

Responsibilities:

• Introduced Minitab software for organization wide implementation for reliability, statistical, and process capability application.
• Implemented risk based statistical sampling to reduce sample sizes and costs by 35% at incoming inspection.
• Developed performance and test criteria for qualifying CAT 6 Ethernet cable as part of NPI process.
• Developed and implementing system level test at suppliers for controller and video processing modules reducing workmanship defects by 15%.
• Developed tool to evaluate PCA complexity relative to supplier technical capability for better FPY.
• Created controller board functional testing for transparent organic LED system reducing failures by 17%.
• Qualified and introduced a new HDMI cable design into functional test stations improving yields by 24%.
• Created measurement systems for 11 product families in the spine market.
• Created preferred supplier program for PCA and PCB suppliers utilizing risk based profiling and qualification techniques.
• Led redesign effort on flex circuit for surgical application to reduce system level failures by 10%.
• Implemented supplier corrective action process which reduced lot rejections by 15%.
• Managed material review board activities reducing on hold inventory by $30,000.

Confidential, Billerica, MA

Senior Supplier Quality Engineer

Responsibilities:

• Provided leadership in upgrading a European supplier's quality system to meet FDA requirements leading to $5 million in US sales.
• Planned and conducted 510k testing on endoscopic disposables.
• Implemented CAPA, process validation, quality planning, complaint handling, MDR reporting.
• Managed the divisions internal audit program and made improvements to streamline the process while maintaining compliance to ISO/QSRs.
• Led successful KEMA and Corporate Compliance Audits resulting in no major findings.

Confidential, Natick, MA

Senior Quality Assurance Engineer

Responsibilities:

• Developed corporate failure investigation procedure to ensure efficient dispositioning of affected OEM product.
• Led catheter R & D teams through the development process including FMEA's, Quality Plans, Process Validation, and finished goods prints.
• Developed corporate external supplier audit procedure to ensure contract manufacturers of finished goods are complying with industry and corporate quality guidelines.
• Audited OEM contract manufacturers for compliance to quality standards.
• Led the corrective action reporting and evaluation process for OEM's to ensure timely resolution of nonconformance issues.
• Developed Quality Plans for OEM supplied product.

Confidential, Andover, MA

Quality Assurance Engineer

Responsibilities:

• Implemented a web site database to provide stores personnel with packaging information and training to reduce Patriot component damage for FLIR systems.
• Introduced new foam packaging trays as part of Kaizen to improve in process handling techniques and reduce module damage as part of an actual reduction of 47% of faults.
• Completed TOW process improvements at DIP and Axial insertion areas by moving reel stations with similar components to reduce wrong component mixups by 100%.
• Led the team quality meetings reporting on scrap, QAD’s, MRB, inprocess quality data, audit outcomes and corrective actions.
• Reduced solder flux faults 100% by utilizing 6 sigma tools to modify the cleaning process from aqeous detergent to turpene.

Confidential, Stoughton, MA

Quality Assurance Engineer

Responsibilities:

• Implemented a calibration system utilizing an MS Access database.
• Led teams through plant compliance audits.
• Planned, developed and implemented an SPC system which improved product quality by 20%.
• Implemented a database to monitor corrective actions for in - process and customer return issues.
• Played lead role in compiling the plant quality manual.
• Led product development teams through APQP and PPAP process.

Confidential, Mansfield, MA

Quality Assurance Engineer

Responsibilities:

• Supervised and motivated QC personnel.
• Implemented in-process quality system to reduce final QC inspection by 33%.
• Completed validation of Citizen screw machine.
• Played lead role in completing qualification of molding test fixtures.
• Conducted supplier audits.
• Developed and implemented in-process corrective action system.
• Led the in-process GMP/ISO audit activity.
• Applied analytical trouble shooting techniques to packaging operations resolving process issues.

Confidential, Haverhill, MA

Quality Assurance Engineer

Responsibilities:

• Developed Gauge and Equipment Calibration System.
• Implemented Quality Assurance Measurement Lab.
• Conducted Supplier Audits.
• Developed Product Reliability Test Program.
• Implemented Statistical Software.
• Implemented Documentation Systems.
• Implemented In-Process Quality Systems for Medical Device and Packaging Processes.

Confidential, Cincinnati, OH

Quality Assurance Engineer

Responsibilities:

• Developed and coordinated process validations for the start-up of a new endoscopic clip applier assembly line.
• Conducted GMP audits of linear stapler product lines and made recommendations in the areas of equipment drawing files, process sheets, preventative maintenance, inspection sheets.
• Designed and implemented gauging for component inspections.
• Conducted statistical analysis to eliminate functional instrument testing on a post sterilization basis.
• Developed protocols for qualification of new, automated staple presence inspection machine.
• Trained and proficient in the following software packages: Statistical Process Monitoring, StatGraphics, Symphony, Excel, WordPerfect, SAS.
• Developed acceptance criteria for Atlas Vac blister pack operation.

Confidential, Milford, CT

Quality Control Engineer

Responsibilities:

• Coordinated implementation of a metal stamping and assembly process for the introduction of a new, improved razor blade spacer.
• Evaluated new twenty-four, thirty-two, and sixty-four cavity molds for process capability and conformance to specification.
• Established quality standards and developed a statistical process control program for a molding operation.