Director of Quality

• Jan 2023 - Present

Director Of Quality

• Oct 2017 - Dec 2022

-Management Representative and owner of all quality compliance/conformance activities for the organization. Overseeing quality team and leading quality initiatives throughout the organization. -Lead Auditor and quality contact lead for all domestic and international Critical Supplier on-boarding and manufacturing activities. (approving quality agreements, managing relationships, guiding changes in the supply chain, establishing expectations in capabilities/validation/product release, leading audits, etc.) -MDD/MDR Technical File owner -Support international regulatory registrations/change notices/reporting as needed

Director of Quality and Regulatory

• Mar 2015 - Oct 2017

Lead and represent all quality and regulatory compliance initiatives within the company (focussed in orthopedics and tissue storage/distribution)Manage multiple facility teams to maintain and exceed compliance with national and international regulations (USFDA, EEA, INVIMA, etc.), ISO standards (13485, 9001, 14971, etc.), customer expectations, and further continuous improvement in conjunction with various department leads.Executive Management team representative to customers, regulators, and standard auditing authorities.

Facility Quality Control Supervisor/Quality Engineer

• Nov 2013 - Mar 2015

•CAPA Coordinator•Customer Complaint/MDR Coordinator•Nonconforming Material Coordinator/MRB member•Recall and Advisory System Coordinator•Deviation System Coordinator•Metrology System Coordinator - Gage R &R studies and calibration scheduling•Internal Audit System Coordinator•Training System Coordinator•Change Management System Coordinator•Supplier Files Management•DHR Management•Front room assistance with customer, ISO, and regulatory audits•Review and Edit SOPs, WIs, Forms, and Labels as needed•Manage 4 direct report in daily functions and team contributions•Identify and establish metrics for reporting to Management Review Meetings•Quality representative to customer for quality related concerns•Work with executive team to implement quality improvement initiatives

RA/QA-Documentation Specialist

• Jul 2012 - Nov 2013

Responsibilities include the following (not all assignments may be listed): •Implementation of a company wide EDMS (MasterControl) •Document Management •Change Control •SOPs, WIs, Forms, and Labeling development •QMS strategy and management •Training coordinator •Customer Complaint coordinator •MDR submittals and investigations •Technical File development and management •Supplier Qualification •Medical device quality inspections •Assist in audit hosting •Assist with Risk Management process and procedures (14971) and 510(k) submission document retention •Assist coworkers in understanding and adhering to FDA, AATB, Council Directive 93/42/EEC, and ISO standards •Staying actively aware on all international Regulatory Affairs changes and news

Quality Associate II

• 2011 - Jul 2012

•Interprets and executes policies and procedures that affect the organizational unit •Acts as a project manager to communicate with new and existing suppliers on an international platform to maintain compliance information and/or documents. •Interacts frequently with a functional peer group. •Assist team members in understanding FDA, ISO and Baxter quality requirements. •Maintains a high level of expertise in current regulatory requirements, and serves as a business resource for compliance to those requirements. •Utilized Trackwise Quality Management System for document control, audit tracking, and supplier quality monitoring based on ISO 9001 compliant processes.

Scientist II

• May 2010 - Aug 2011

•Played a key role in establishing detail oriented field projects that created precise results in highly developed studies for private utility companies, legal clients, state and federal regulators •Implemented key software tools for reporting critical data in reports to project managers and our clients •Data analysis/processing and documentation of field data into a company-wide filing system for verification and quality monitoring, including making sure that documenting procedures were consistent across all departments within the company Technician II May 2010 – January 2011 (9 months) •Assisted project development in studies lead for private (utility, energy, and legal), state (DOT, DEP, etc), and federal clients (EPA). •Participated in the collection and analysis of water quality monitoring, temperature surveys, tagging and tracking studies, soil quality, fish tissue sampling, and marine habitat and population data to determine precise results for small and large projects. •Also worked in lab analysis function examining collected field samples. •Promoted to a 'Scientist II' role.