Manager Quality
Resume:
Jean M. Burns
Millis, Massachusetts 02054
Email: ********@*****.***
Summary
A seasoned Regulatory Affairs, Quality, and Compliance. Built successful quality systems and integrated them into overall corporate quality systems. Proven ability to build strong internal and external relationships that strengthen vendor and regulator relations to effectively address regulatory and compliance issues. Implemented aggressive CAPA system to identify, address, and communicate issues.
Experience
09/2000 – Present Terumo Cardiovascular Systems, Inc., Ashland, Massachusetts.
06/2007 – Present Quality Manager
• Coordinated recall activities, interacting directly with the FDA and Health Canada, additionally managed the MDR and MPR reporting processes.
• Reviewed and submitted Health Canada medical device licensing applications.
• Pre- and post-approval of product validation testing, including testing for 510(k) submissions.
• Designed, created and approved product labeling to meet corporate and regulatory standards.
• Responsible for hiring, training, and supervision of eight direct reports.
• Maintained Device Master Record and Technical File for all Ashland products.
• Ensured that the Ashland division adhered to cGMP and ISO 13485 regulations.
09/2000 –06/2007 Quality Chief
• Managed and refined quality system for ISO 13485 certification in a class ISO 8 clean room facility.
• Performed Management Representative duties.
• Oversaw CAPA system, raw material inspection, post-sterilization product release, audit system, and document control system.
• Interfaced regularly with production, sales, engineering logistics, and regulatory affairs to ensure that project and process improvements are consistent with corporate goals and standards.
• Spearheaded a project that transitioned all Instructions for Use from paper to CD-ROM format.
3/1995 – 9/2000 Mead Specialty Paper Division, South Lee, Massachusetts.
2/1999 – 8/2000 Supplier Quality Manager
• Oversaw supplier product specifications, supplier quality audits, and resolution of raw material quality issues.
• Supported ISO 9001 through maintenance of supplier corrective action requests (SCARs)
• Interfaced regularly with purchasing department; supervised two raw material inspectors.
3/1995 – 2/1999 Laboratory Manager
• Managed the operations of two product testing labs.
• Responsible for supervision, training, and hiring for a staff of twenty employees.
• Accountable for equipment maintenance, calibration, and upgrades.
• ISO 9001 auditor.
Education and Certifications
• MS, Health Product Regulation, Regis College, Weston, Massachusetts.
• Graduate Certificate in Health Product Regulation, Regis College, Weston, Massachusetts.
• Graduate Certificate in Clinical Research, Regis College, Weston, Massachusetts.
• Manager of Quality/Organizational Excellence, American Society for Quality, Certification Number 7163
• MBA, Thomas College, Waterville, Maine.
• B.S. University of Lowell, Lowell, Massachusetts.
Chemical Engineering with minor concentration in Pulp and Paper Engineering and Economics
Professional Associations
• Regulatory Affairs Professionals Society (RAPS)
• American Society for Quality (ASQ)
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