Manage the Quality Management System including: • CAPA system (Initiation to Closure) • Document Change Control / Record Control • Management of QMS software including workflow updates and validation• Batch Record Review/Release • NCMR • Trending • Auditing (Internal and Supplier Audits)• Inspection readiness program and hosting audits• Facilitate management review meetings • Manage the supplier quality system by evaluation and approval of new or existing suppliers. • Develop internal training modules such as: Root Cause Analysis, QMS, ISO, cGMP, GDP• Implemented auditor training programs (internal and supplier audits) • Provided on-site training / qualification of new auditors • Mentor for junior level quality engineers and quality support staff

Responsible for managing eleven direct reports; 7 document control specialists and 4 quality engineers. • Manage the CAPA system ensuring appropriate CAPA are initiated, investigated and closed in a timely manner. • Developed and implemented a site inspection readiness program insuring (customer, regulatory, internal or corporate). Host 3rd party audits such as FDA, ISO, customer and corporate. Manage front and backroom activities during regulatory audits; managed remediation activities and providing updates to regulatory bodies as necessary.• Facilitate management review meetings • Trend /monitor site KPI’s and report on a regular basis. • Manage the supplier quality system • Manage the NA internal and supplier quality audit program • Developed and implemented auditor training programs (internal and supplier audits) • Manage the writing, reviewing, approving and publishing all site and North American documentation. • Responsible for the QA review of annual product reviews (APRs)

Responsible for managing the quality engineers associated with the Hemostasis product line. Managing the quality system including CAPA, supplier quality, internal and supplier quality audits, semi-annual QSMR and customer complaint investigation process.

Developed and implemented a quality system including document control, in process testing, workmanship standards, employee training, internal and supplier auditing, systems evaluation and KPIs.

Responsible for managing the CAPA process, customer complaint investigation process including management of 4 full time employees. Performing root cause analysis investigations and developing customer responses. Managed the collection and presenation of QSMR data, training of site staff, supporting the front room FDA inspections, interfacing with FDA with regard to areas of responsibility. Managed the continuous improvement cross functional team.