Carmen Morton Email & Phone Number

Bristol, Ct, Us

Berlin, Ct, Us

Quality Management System (QMS) Compliance- Ensure adherence to QMS, international standards, internal processes, and regulatory requirements.- Understand QMS elements, controls, processes, and procedures.- Comply with FDA and ISO 13485 requirements.Continuous Improvement and Metrics- Drive initiatives for continuous improvement.- Monitor organizational and quality system metrics (e.g., supplier performance).Audit Management - Manage and conduct supplier, internal, ISO/regulatory, and customer audits.- Manage and qualify team of internal auditors to comply with ISO standards and FDA regulationsCorrective / Preventative Actions- Administer corrective/preventive actions.Complaint Handling and Nonconforming Material Control- Investigate and analyze customer and supplier complaints.- Handle nonconforming material, ensuring identification, traceability, and containment.System Administration and Documentation- Perform system administration tasks - Manage databases and records - Control documentation systems and record retention.Change Control and Engineering- Process document/engineering change orders.- Manage product libraries (PLM controls).Training and Regulatory Knowledge- FDA regulations, good documentation practices, and 21 CFR Part 820.- Understand ISO 9001:2015, ISO 13485, and ISO 17025.- Familiar with class I, II, and III medical devices and regulated manufacturing industries (aerospace, defense, pharmaceuticals).

Little Rock, Arkansas, Us

Experienced Professional • Evaluating prospective and approved suppliers • Executing and maintaining quality and non-disclosure agreements for critical suppliers• Managing Supplier Complaints to ensure corrective actions address non-conforming material issues.• Managing, reviewing and assessing supplier notifications of changes • Trending supplier performance through routine analysis of quality metrics• Tracking and trending customer and supplier complaints • Monitoring suppliers' registrations, licenses, and public regulatory information to ensure supplier regulatory compliance• Monitoring changes to regulatory, ISO and USP requirements • Performing internal audits to verify adherence to standard operating procedures and continuous improvement• Performing virtual and on-site supplier audits to ensure quality standards are met.• Qualifying new suppliers and re-qualifying existing suppliers• Request replacement or credit from suppliers for defective raw materials• Reviewing and updating standard operating procedures, position papers, and other company documents, as required • Supporting all elements of the Quality Systems group.• Reviewing certificates of analysis and conformance for accuracy• Reviewing shipping records and temperature traces for domestic shipmentsThorough knowledge of• USP, FDA, DEA, ICH regulations, Good Documentation Practices• FDA 503B regulations, 21 CFR Parts 210, 211, 600 and 820 collectively GMP• ISO 9001:2015, ISO 13485, ISO 17025• REACH, Conflict Minerals, RoHS, EAR, ITAR, Prop65, TSCAAdvanced level skills• Great Communication, Collaboration, Multi-Tasking, and Project Management• Microsoft Office (365) Suite, Adobe Acrobat, Altec DocLink, Sage, Snap-R, Zoom

 Submit Export License applications to the US Department of Commerce Bureau of Industry and Security via SNAP-R. Monitor and track License approvals, associated Rider and Conditions, and Export License Exceptions Monthly reporting of export license requirements Determine Export Classifications and Harmonized Tariff Schedule numbers for US & Canada Products Conduct Restricted Party Screenings via Visual Compliance Manage Export Document – o Policies, procedures and work instructions.o Licenses, nuclear certification statements, strategic trade authorizations and destination control statements. o Shippers Letter of Instructions, Export Declarations, Certificates of Origin and/or Manufacturer's Affidavits etc.o Certificate of Origins, USMCA, Customs Invoice Free Trade Agreements (USMCA, CAFTA, US-Chile, etc.),  Record keeping requirements. Facilitate shipments with Customers, forwarders and carriers

Southingon, Ct, Us

 Ensure the most up-to-date versions of documents are accessible to employees Maintain accuracy of Quality Manual Policies, Procedures & Work Instructions Ensure the right employees have access to the right documents Prepare and report monthly , quarterly, and yearly reports, organizational charts, auditso Inventory Cycle Countingo Management Reviewo Return Material Authorizations Reports & Chartso On Time Delivery Reportso Customery Survey Resultso Customer Reviews (scorecards) of Yarde Metalso Supplier Performance Reports Develop and maintain Quality/Purchasing Intranet contents Maintain documents and forms for all departments within the corporation Maintain the Quality Management System, Material Safety Data Sheets, Standards, Corrective/Preventive Actions, Stamps,  Assist with the Certification Process

Bs, Business Administration

Certificate Of Completion, Supplier/Contractor Qualification And Management