Manufacturer of implantable surgical devices. Key leader on initial start up team for Arthrex's greenfield manufacturing facility in South Carolina. Responsible for the hiring of the initial Quality organization, as well as equipment and facility qualification activities. Led initiative to integrate the new facility into the existing Arthrex Quality System, and the site received ISO 13485:2016 and MDSAP certification 5 months after building occupancy.

Manufacturer of sterile contact lens solutions and general eye care products. Aseptic filling and high speed packaging of >150 million bottles per year. Responsible for all areas of Quality Assurance and Quality Control for aseptic manufacturing of sterile solutions, including compliance, manufacturing quality, chemistry, and microbiology.

Manufacturer of sterile contact lens solutions and general eye care products. Aseptic filling and high speed packaging of >150 million bottles per year.Responsible for Quality Engineering, in-process inspection, final product release, and complaint handling for a manufacturing facility of ~400 employees that operates 24 hours a day, 7 days a week. Oversee a staff of 27 direct reports. Partner cross-functionally with Planning and Operations to ensure timely release of product. Address nonconformances as necessary, ensuring appropriate root cause analysis and identification of corrective action plans. Perform routine internal audits of Quality Systems and manufacturing operations to identify areas of risk and opportunities for improvement.Perform routine trending of metrics related to manufacturing performance and the performance of product in the field. Develop annual product quality reviews, and ensure appropriate feedback into product design and risk management files.

As the Senior Manager of Quality Systems and Compliance, I led a turnaround in Quality Systems performance. The facility went from one known as a potential compliance risk to one that received no external audit findings (FDA, Notified Bodies, customer) through 11 audits over 3 years. Focused on improvement of CAPA, nonconformance and change management processes. Implemented Global systems for change management, document management, electronic learning management systems.

Site Quality Leader for intraocular lens manufacturing facility.Maintained Quality System in compliance with 21 CFR 820, ISO 9001, ISO 13485, 93/42/EEC, and CMDR. Developed and managed staff of 20+, responsible for all areas of QA, including incoming inspection, final product release, document control, environmental monitoring, sterilization (steam, ethylene oxide and gamma irradiation), microbiology, complaint handling, quality engineering, and all aspects of compliance, including training, internal and supplier auditing and validation.Facility consistently received highest compliance rating within Bausch & Lomb from 2006-2009. Training, validation, internal audit and CAPA systems considered as benchmarks in the organization.Established local change management and nonconformance management processes. Improved processes for document control, label changes, CAPA, supplier management, annual product review, risk management, training and certification. These improvements resulted in more business-friendly systems, which were both compliant and flexible to business needs.Partnered with Operations and Engineering on program to identify and implement $5 million in site cost improvement projects.Analyzed and reported key operating metrics to local and Global management, using these measurements to drive improvement within the organization. Developed annual Master Validation Plan and Site Quality Plan.Led successful certification upgrade effort for ISO 9001:2000 and ISO 13485:2003. Hosted FDA facility inspections.Reduced post-sterilization testing costs for all product lines by reducing required testing and validating internal test methods; resulted in a cost reduction for one product line of 44%.

Managed staff of four, which was responsible for on-going activities of CAPA, internal audit, supplier quality, validation, training, document control and complaint management systems.Managed third party certifications and audits, including 2 different notified bodies, as well as the FDA.Supported all phases of development, validation and transfer of new product lines from pilot to full-scale production.Provided QE support for various product lines representing approximately 70% of facility production. Performed root cause investigations and developed corrective and preventive action plans as necessary, using quality tools such as PFMEA, DOE, SPC, and process mapping to identify and monitor critical processes. Led and participated in cross-functional Six Sigma and Lean Manufacturing teams to implement process improvements and cost reduction initiatives.

Instrumental in the qualification and start-up of a new manufacturing facility, including qualification of all equipment and facility systems. Management of all of the Quality Control functions of in process and finished device inspection ensuring compliance with internal, corporate and regulatory requirements.Provided technical support and supervision to all quality inspectors and production personnel. Chaired the Material Review Board, ensuring review and disposition of all nonconforming product and material.

Performed gap analyses in to identify systems weaknesses in support of successful implementation of ISO 9001.Developed and implemented internal audit program.Performed design and process validations including writing of protocols, collecting and analyzing data, and generation of summary reports.