• Direct department activities as required to establish and maintain global regulatory compliance.• Ensure that all product labels, classifications, certifications and disclosures comply with international, federal, state, and local rules and regulations.• Manage regulatory compliance of products manufactured and/or marketed in Canada, EU, China, Korea, Japan, Singapore, Central/South America, India and Australia. • Extensive experience managing compliance to OSHA, GHS, TSCA, REACh SVHC’s, RoHS, PFAS, Prop65, Carb, VOC’s, China REACh, Korea REACh, EU Poison Centre Notifications (PCN).• Manage development and authoring of new product SDS’s while continuously updating existing product SDS’s as needed to comply with formulation changes and applicable regulation updates.

• Provide objective advice to organizations on strategies to improve the quality of products.• QMS authoring, implementation and certification. Gap analysis and remediation of existing QMS.

• Drafted, implemented and certified company to ISO 9001:2015 standard. • Developed company KPI’s to drive efficiency and employee performance.• Manage customer complaints, investigate and remediate product issues. • Manage Inspection Department and associated activities; NC's, DMR's, FAI's. • Identified/improved numerous product issues and manufacturing processes. • Develop/manage supply chain quality expectations and relationships, reduced defect rate. • Support Engineering, Product Testing, Manufacturing, Purchasing, and Customer Service.

• Drafted and implemented corporate Quality Management System (QMS). • Implemented Equipment Dept. calibration program to meet compliance requirements. • Drafted quality requirements for major project bid packages submitted to clients. • Created internal auditing program, perform audits of key business processes. • Conduct system failure investigations, determine root cause/implement corrective action. • Implement Environmental Policy, provide guidance to maintain social responsibility compliance.

• Manage ISO 9001, supplier management, and continuous improvement programs. • Prepare customized report packages for FAI determinations using PPAP, AS9102, etc. • Ensure product compliance to REACH, RoHS, PAH, etc. directives per current EU requirements. • Oversee customer complaints, product investigations, drive corrective actions to completion. • Certify new suppliers/contract vendors, ensure suppliers meet increasing quality standards. • Chemical Hygiene Officer, manage SDS system, oversee company safety training program.

• Lead activities to implement (first) commercial testing and release of stents in USA. • Implemented calibration program for laboratory analytical instrumentation. • Analytical equipment manager for laboratory, OEM service contract administrator. • Directed OOS investigations, implement corrective action, corporate CAPA member. • Raw materials (pharma) test manager, authorize release to commercial manufacturing. • Department safety representative, manage hazardous waste stream, train new employees.

• Directed Quality Department activities to achieve ISO 9001:2000 certification. • Manage laboratory operations/personnel to ensure product quality and food safety compliance. • Ongoing statistical analysis of sampling data to drive optimization of manufacturing processes. • Developed and validated product release testing per regulatory compliance requirements. • Perform GMP/Safety audits of plant operations and personnel, ensure remediation of issues.