SUMMARY:

• Implements process improvements throughout product lifecycle.
• Expert in Risk Management and Compliance.
• Solutions driven, analytical and creative Certified Manager of Quality, Certified Quality Engineer and Six Sigma Black Belt with extensive experience in Medical Device Industry.
• Risk Management | Six Sigma and Lean Methodologies | Design Controls CAPA & NC Internal & External Auditing | Quality Issue Escalations | Labeling SPC | DOE | QMS | Statistical Techniques | Process Improvement | cGMP

TECHNICAL SKILLS:

Microsoft Office Suite (including Excel, VISIO, MS Project and Publisher), Minitab, Statistica, InfinityQS SPC, AutoCAD, SolidWorks, SolidEdge, ProEngineering, ProMechanica, FeatureCAM, Inventor Autodesk, MathCAD, Primavera Project Planner, Visual Basics, Adobe Photoshop Lightroom and Adobe Photoshop.

PROFESSIONAL EXPERIENCE:

Confidential, Irving, TX

Staff Quality Engineer

Responsibilities:

• Designated as Risk Management Subject Matter Expert during MDSAP/FDA audits and internal audits. Maintained successful track record of no Risk Management related findings during external audits.
• Lead New Product Introduction (NPI) Quality Engineering activities in product commercialization projects, from product concept to launch, including clinical studies and post market surveillance. Supported R&D and NPI throughout every design control stage by devising quality strategy, providing statistical support and validation input. Focused on Design to Value and Risk reduction. Lead, drove and maintained Risk Management activities on new products.
• Lead Quality Engineering efforts in Product Life Cycle Management projects (Design Changes, Design Line Extensions and labeling changes). Updated FMEAs, Risk Assessment Summaries and Risk Management Reports to reflect design changes.
• Developed and implemented action plans to solve quality issues through NCs, CAPAs and Internal Audit actions to address Quality Life Cycle Management Issues, such as product labeling, distribution, registration and others. All NCs, CAPAs and other deliverables were closed within approved timelines and proven effective.
• Represented Mentor during Risk Management alignment efforts with Ethicon, and subsequently with J&J’s Medical Devices &Diagnostics sector. Ensured Mentor product specific risks were represented in sector’s procedures. Provided training to process changes to local team and held periodic update meetings with Mentor leadership.
• Lead improvement to Breast Implant, Expander and Sizer product family Risk Management files to ISO14971 Standard. Managed Risk Management by analyzing product performance data and executing the development or updates to FMEAs, Risk Assessment Summaries and Risk Management Reports.
• Lead the transition of Product Artwork Relationship Matrix (PARM) process into Mentor LCM group. Maintained ownership of PARM, coordinated and implemented changes associated with labeling projects impacting the European Distribution Center.

Sr. Quality Engineer

Confidential

Responsibilities:

• Managed Product Quality Issue (PQI) Escalations program.
• Lead investigations, remediation efforts and was key contact between PQI owners and Quality review board.
• Lead the quality efforts and ensured timely completion of following projects:
• Analyzed product performance data and executed the development or updates to FMEAs, Risk Assessment Summaries and Risk Management Reports.

Sr. Quality Operations Engineer

Confidential

Responsibilities:

• Managed Traceability Department and Quality Assurance Technicians (4 direct reports).
• Ensured complete and timely trace activities, including release of finished product.
• Performed yearly goal setting and performance appraisal.
• Assigned as New Product Introduction Quality Engineer for the new Tissue Expander (CPX4) Project and Ultra High Profile Memory Gel (UHP) Project.
• Authored Quality Plans, pFMEA, dFMEAs, aFMEAs, Risk Management Report and lead Overall Residual Risk Meetings.
• Ensured timely delivery of all quality tasks.
• Assigned as CAPA/NC Site Lead back - up. Opened CAPA’s and lead CAPA review meetings.

Quality Engineer

Confidential

Responsibilities:

• Developed an On-line Process Monitoring of Seal Strength in the Primary Packaging department.
• Through DOE’s and SPC, lead project that transitioned the seal strength testing from Finished Device Testing to in-line monitoring. Reduced waste by $60,000/year.
• Lead key projects required for Mentor’s integration into Confidential & Confidential QMS
• Validated laboratory tests methods for Gel Cohesion and Non-volatiles Content.
• Lead the implementation of Wood Pallets Inspection Policy. Trained personnel.
• Participated in the development of NC teams.
• Lead Risk Assessment training.
• Drastically reduced NC closure time and set standard for quality and timeliness.

Confidential, Angola, IN

Quality Engineer/ Engineering Administrator

Responsibilities:

• Lead company transition to the new ISO 9001:2000 standard by achieving several independent surveillance audits with no Non-Conformities findings.
• Managed and performed internal audits, lead root cause analysis and assured completion of quality plans.
• Assured compliance and preparedness for independent surveillance audits and customer audits.
• Coordinated audit response; implemented preventative and corrective actions.
• Developed systems to gather data and performed real-time SPC analysis to bring Confidential ’s main processes to control state.
• Authored and implemented operating procedures, equipment preventative maintenance procedures and forms.
• Managed laboratory and performed production and raw material testing using Optical Emission Spectrometer.
• Responsible for Spectrometer’s calibration, compliance and preventative maintenance.
• Developed and lead employee trainings, such as new employee orientation, ISO basic training, internal auditor training, Excel training and spectrometer operator training.