Michelle Pulaski, Cqa Email & Phone Number

Caledonia Michigan

• Quality Management Representative & Official Correspondent • Customer Complaint Investigations, Customer Deviation Requests • Developed and manage the Internal Audit, Client Audit & Supplier Audit Programs • Developed, Monitor and Measure established Quality Goals & Objectives • Quality/Regulatory interface for FDA, Notified Body & Customer Audits • Quality in the manufacture of class I & II disposable and implantable medical devices • Manage Document & Records Control • Manage the company CAPA Program

• Quality Management Representative & Official Correspondent• Customer Complaint Investigations, MDR submissions, Vigilance Reporting• Developed and manage the Internal Audit, Client Audit & Supplier Audit Programs • New Product Development – Design Controls• Developed, Monitor and Measure established Quality Goals & Objectives • Quality/Regulatory interface for FDA, Notified Body & Customer Audits• Quality in the manufacture of class I & II disposable medical devices• Manage Document & Records Control for 3 Quality Systems • Manage the company CAPA Program

• Developed, Managed and participating in the Internal Audit, Client Audit & Supplier Audit Programs • Quality/Regulatory interface for FDA, Notified Body & Customer Audits• Monitoring and Measurement of Established Quality Goals & Objectives • Managing and participating in the CAPA Program• Customer Complaints Coordinator, responsible for investigations and meeting client reporting requirements• New Hire and All Employee Training for cGMP, ISO & Internal requirements• Back up Quality Management Representative

Education record

Education record

Cqa, Certified Quality Auditor