• Introduced key process efficiencies in multiple areas to reduce non-value added work and documentation resulting in improved performance in post market product analysis.• Implemented cross-training across various functions to ensure redundancies allowing for no stoppages in work output following a 42% reduction in personnel. • Maintained quality agreements with various LivaNova entities that perform distribution activities on behalf of the Neuromodulation therapeutic area. • Leads, manages and develops direct reports by preparing objectives and metrics, communicating expectations, improving technical capabilities and measuring results against these goals.• Develops and maintains effective relationships with internal personnel and external stakeholders to facilitate and drive the resolution of regulatory compliance and product quality issues.• Interacts with external industry or regulatory bodies. Includes participating in internal and external audits and responding to any identified nonconformities.• Develops, reviews and approves quality system documentation such as procedures, NCRs, and other investigations (e.g., complaint, CAPA). • Acts as business process owner of the nonconformance report (NCR) management system, including material review board (MRB) approvals, monitoring the timeliness and effectiveness of the system and activities;• Reviews changes for completeness and technical accuracy and leads the identification of impacts related to the change.• Ensures finished devices meet their acceptance criteria and were manufactured in accordance with the DMR.• Liaises with Operations to ensure that finished devices are released in a timely fashion.• Coordinates and/or performs supplier and internal quality audits as necessary.• Reports on departmental performance for Management Review and other review mechanisms.• Participates in cross-functional teams assembled to investigate and resolve product quality issues.

All responsibilities of a Clinical Quality Engineer, minus training of new CTS hires.Was the quality representative on rebranding efforts including implementation of labeling changes to address name change.Worked with Information Development to identify country and business specific labeling requirements. Was the quality representative for process changes including removal of redundant inspection steps occurring in the warehouse, introduction of new equipment for a slight change in sterilization method, implementation of SAP as a ERP system for sales and distribution while still maintaining legacy system, QAD, for manufacturing.Routinely review and approve documentation updates for changes to manufacturing procedures, quality procedures, and work instructions.Review and approves equipment evaluations when equipment has been identified to be out of calibration or needs to be replaced with new equipment.Ensures all quality requirements are met when inducting new equipment or making process changes.Provided input at the global level for changes to distribution requirementsImplemented changes to the post market surveillance process as a result of implementation for the new process for clinical evaluation and post market surveillance.Train new QEs to post market surveillance, the basics of NCRs, and FAIs.Managing team of 7 technicians in Product Analysis:Implemented process changes in Product Analysis to eliminate any unnecessary and non-value added activities.Guided technicians on implementing process changes that reduced overall expenses from the department.

Monitored post market product performance (i.e. complaints) and identified trends that warranted investigation under the company's CAPA process.Lead several CAPA root cause investigations for both product and process related issues and developed and implemented effective corrective actions to address the root cause(s) while meeting established timelines for action completion.Developed and provided advanced technical training to the Clinical Technical Support TeamPlanned and performed internal audits to evaluation the quality systems throughout various areas in Cyberonics to ensure compliance with applicable regulatory bodies and international standards. Certified to ISO 13485Trained new complaint investigators for Clinical Technical Support.Trained new CQEs on the complaint process.Provided Quality System training to new company hires.Participated in a back-log complaint file closure project and closed hundreds of complaints within a few months.Collaborated with a cross functional team to draft and submit a response to FDA regarding Vocal Cord Paralysis incidents.

Identified and investigated complaints in accordance with company procedures, FDA and international regulations, as applicable.Prepared and submitted MDR and MDV reports within the required timeframesManaged own workload to maintain file aging within department metricsTrained new employees on the complaint handling process including submitting MDRs.Updated and trained a team to execute validation testing for v8.1.3.

Lead a group of 4 complaint investigators that grew to 10 in 5 months, in a supervisory role, while continuing to perform the functions as a complaint investigator.

Identified and investigated complaints in accordance with company procedures, FDA and international regulations, as applicable.Prepared and submitted MDR and MDV reports within the required timeframesManaged own workload to maintain file aging within department metricsTrained new employees on the complaint handling process including submitting MDRs.

Actively participated in resolving escalated customer concerns which included providing data analysis, troubleshooting techniques, design of in house experiments, and recommendations on how to best avoid future concerns. Performed customer site visits to ensure proper use of the product as well as to improve business relationships. Investigated and finalized all concerns related to animal applications and other off label uses of DSL products. Provided laboratory training, product training, and administrative training to incoming application scientist. Worked to increase the product knowledge of sales force by developing training materials such as slideshows and quick reference spreadsheets as well as provided education on the utilization of DSL products in the field.Was required to make independent decisions on how to resolve customer issues by utilizing establish procedures and practices. Had to provide supporting data and documentation to Regulatory Affairs and Quality Assurance on a regular basis.

Assisted customers in troubleshooting of any product related issues that occurred at their facility. Communicated customer expectations and inquires to the respective departments and worked to developed methods to meet customer needs. Provided training to sales force to ensure that product performance limitations were properly explained to customers. Provided customer history and ongoing product issues to managers and sales team at inter-department meetings. Designed spreadsheets to capture all the complaint related information in an easy to use and detailed format. Documented all complaints in compliance with company procedures. Actively participated in FDA and Health Canada audits. Provided training to incoming Customer Complaint Coordinators.Was required to make independent decisions on how to resolve customer issues by utilizing establish procedures and practices. Had to provide supporting data and documentation to Regulatory Affairs on a regular basis.

Performed final testing on various immunoassay products manufactured by DSL prior to distribution to customers. Utilized ELISA, EIA, IRMA, and RIA techniques. Programmed semi automated instruments to perform testing on specialized products. Maintained calibrations records of personal laboratory equipment as well as some of the general laboratory equipment. Performed troubleshooting on problematic products. Provided data summaries as requested for various laboratory projects. Assisted in training of incoming laboratory personnel.