Regulatory and Quality Manager
Resume:
Katya Magee
Oak Park, IL 60302
Phone: 248-***-****
*****.*******@*****.***
Dear Corporate Representative,
I am writing with interest in your Software Quality Manager position. I enclose a copy of my Resume for your consideration.
As you will see from my Resume, I am currently working for Leica Microsytems Inc as the Compliance Manager, overseeing
the regulatory and quality affairs for the global FDA and Health Canadian markets, as well maintaining the ISO:9001
accreditation for the site. My strong organization skills have led to develop a benchmark process for a problem solving course
and provided global support for our company in audits as well as CAPAs. Recently I have created a visual management daily
display for our CAPA system and supplier management scoring systems which has decreased the CAPA cycle time and
allowed executive management instant visibility to progress with OEM suppliers.
In the past 6 months, the implementation of an electronic supplier management qualification program has decreased the
supplier review process by 50% using current personnel and restricting processes. Additionally, I have validated, tested and
maintained compliance for our global complaint handling system for all 13 Leica Manufacturing sites through a software
program. This has increased consistency in quality defect tracking and reporting.
With my proven ability to manage and maintain the highest regulatory and quality standards whilst also minimizing costs, I
feel that I would be able to make a significant contribution to your company's management team.
I would be grateful if you would contact me if you have any vacancies in your company, or keep my information on file in
case of future openings. I would welcome hearing from you.
Yours sincerely,
Katya Magee
1211 N. Ridgeland Ave
Oak Park, IL 60302
Phone: 248-***-****
Email: *****.*******@*****.***
Enclosed Resume
Katya Magee
1211 N. Ridgeland Ave.
Oak Park, IL 60302
Phone: 248-***-****
*****.*******@*****.***
Career Summary:
• Manage, plan and coordinate all activities in the Regulatory affairs department in the following regulations:
HIPPA, FDA, Health Canada, ISO 9001, ISO 13485, ISO 17025, GMP guidelines
• Consistently receive above average or exceeds for performance reviews in clinical business operations,
research database systems, leadership skills, with a diagnostic medical technology background.
• Develop, test and maintain software validation script writing/execution, training, mentorship of end users,
and support of customer service resolution for complaint handling software.
Achievements:
• Received ISO 17025 Accreditation within 6 months of initiation of process changes at Leica Microsystems.
• Integration of 3 Medical Device acquisitions to the Leica Brand QMS system in 2 years.
• Increased efficiency and corporate harmonization of 13 Leica Manufacturers’ complaint handling systems
through a global complaint handling over 2 years of software validation, end user training and support,
change control documentation and validations at each site.
• Decreased the turnaround of a supplier qualification by 50% and the inventory of suppliers by 60% by
implemented a supplier management program with electronic routing for supplier qualification based on
risk of supplier services/product provided using current personnel and restructuring processes.
Experience
LEICA MICROSYSTEMS
COMPLIANCE MANAGER SEPTEMBER 2012-
CURRENT
Implement and maintain quality systems to assure GMP/ISO compliance, including document control, internal
auditing, training, and product licenses for Health Canadian and FDA registration for all 13 Leica Manufactures.
Develop and implement procedures for the review and release of clinical materials and commercial marketed
Cancer Diagnostic products and Clinical Microscopy products.
• Benchmark audit readiness of the Leica global manufacturing facilities for regulatory inspections and client
audits- 3 successful FDA manufacturing site audit; 3 successful Health Canada audits- 1 selling unit, 2
manufacturing sites.
o No Major findings in 3 years, 2 Minors in 3 years through 8 audits for North America
• Global Triage Support for Regulatory and Quality departments for all 13 Manufacturing sites during
acquisitions and performance failures to return the site to audit readiness.
• Achieved AAMI certification for software validation of quality system processes and nominated as the lead
to restructure the validation process for the current and future quality software systems to ensure FDA
compliance.
• Global Leica supplier auditor for ISO 13485
o 5 supplier audits on behalf of global procurement team with actions plans completed within 6
months by the supplier and decreased PPM for 2 largest OEMs.
• Decreased Corrective and Preventive Action cycle to 90 Days through a daily management visual tollgate
program for all CAPA owners and executive management review.
• Develop regulatory strategies for new medical devices and changes to existing product line distributions-
recent Caribbean Island and South American initiative for indirect sales team to use the electronic
complaint handling system.
• Zero late submissions for Corrective Actions and MDRs for Corrections & Removals for all 11 Leica
Manufacturers internationally.
• Conduct corporate compliance Investigations and employee training related to Physicians Payment
Sunshine Act and Danaher Corporate policy for Anti-Corruption.
LEICA MICROSYSTEMS
REGULATORY AND QUALITY ASSURANCE SPECIALIST SEPTEMBER 2011-SEPTEMBER
2012
• Composed relevant and concise standard operating procedures to eliminate additional procedures and
technical documentation, building a relevant and manageable QMS for Leica North America.
• Restructured the internal audits program to assure compliance with company procedures and government
regulations for audit-readiness in external audits.
• Conducted Quality Management System Training within the organization on the importance of meeting
customer as well as statutory and regulatory requirements (electronic course, WebEx, interactive) for all
employees.
• Facilitate Manufacturers and Suppliers corrective actions for immediate and long term goals with quality
reliability initiatives that reduced Leica’s overall defect rate by 30% year over year.
Northshore University HealthSystems
MICROBIOLOGY ASSOCIATE AUGUST 2010-
AUGUST 2011
• Executed and analyzed tests in areas including bacteriology, virology to aid physicians in diagnosing
and treating disease.
• Consistently high performance reviews for the timely, high-quality completion of both routine and
special laboratory assays of patient specimens (molecular diagnostics, skin and biopsy samples.)
• Demonstrated the ability to communicate test results effectively with physicians, pathologists and
nursing staff as a member of interdisciplinary team focused on providing exemplary quality of care.
• Commended performance analyzing laboratory assays and resolving complex clinical and instrument
problems.
Core Laboratory Associate
July 2009 – August 2010
• Executed and analyzed tests in areas including chemistry, hematology, urinalysis, and serology, both
automated and manual differential analysis.
• Selected to specialize in bone marrow and peripheral smears related to progression of disorders and
classification of diseases to verify abnormal results with appropriate test results.
• Proficient identification of tumor markers/antigens and their affiliation with certain diseases
EDUCATION and Certifications
AAMI Software Validation
April 2015
Danaher Problem Solver Trainer June
2012
ISO 13485 Lead Auditor Certification
December 2011
ASCP Board of Registry Exam July
2009
Northshore University Healthsystems-Evanston Hospital
July 2009
Medical Technology Program
• Trained and certified as a Medical Technologist in a fast-paced workforce in all areas of the lab, working
side by side with current technologists in the following areas: Clinical Chemistry, Urinalysis, Blood Bank,
Hematology, Microbiology, Immunology
Michigan State University
Bachelor of Science Degree in Medical Technology
August 2008
SKILLS
• Utilize Microsoft Systems: Windows, Word, and PowerPoint with Pivot Tables
• Utilize Lotus Notes Applications and SAP, Outlook
Contact this candidate