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Medical Device Quality

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Location:
California, 92270, United States
Posted:
June 13, 2012
Email:
cxplsh@r.postjobfree.com
Contact Info:
*******@***.***


Lori Patoros, RN, IBHRE, CLNC
** **** ****** *****
Rancho Mirage, CA 92270
cxplsh@r.postjobfree.com
Cell: 760-***-****

SUMMARY OF QUALIFICATIONS
Regulatory and Quality
• Analyzes medical records, device history, policy and procedures to prepare a comprehensive review of medical device usage through charts, graphs and statistical information for current issues and offer recommendations.
• Consultative resource on legal issues related to allegations of device function.
• Assists in preparation of quality reports; such as Product Stewardship, Post Market Surveillance, Corrective and Preventative Actions (CAPA), and Value Added – Value Engineered (VAVE) initiatives that are sent to senior management, stake holders, and regulatory bodies.
• Knowledge of current FDA and CE Marking submission process for class III and class I devices. Experience in implantable devices, hardware, and software.
• Monitor compliance with internal policies as well as international, federal, and state regulatory requirements including FDA, ISO and IEC.
• Principal clinical resource between the manufacturer and thousands of international customers.
• Reviews data for appropriateness of device use and standards of care.
• Developed and delivered educational programs for internal and external customers related to compliance, quality, and safety.
• Supports life cycle of product line. Responsible for product management, marketing, and training for the entire Medfusion® Syringe Pump portfolio.
• Meets with local FDA team to offer real-world clinical use and determination of issues.
• Established cross functional team to develop requirements for multiple new products in regards to customer needs and marketing vision using best practices and evidence based medical practices.
• Executed several focus groups and pilot studies to ensure new product development followed clinical applications and reduced human error interface issues.
• Coordinate cross functional team with key opinion leaders to create enhancements for products to decrease programming errors thereby increasing customer satisfaction and loyalty to product line.
• Author of international device evaluation protocol and troubleshooting tips, thereby creating a more concise and consistent evaluation process which provides a higher quality of care.

Quality Improvement
• Investigates problems encountered by customers; identify patterns and trends to develop policies and procedures to improve quality.
• Prepares reports on liability cases with trends and issues regarding safety and offers quality improvement strategies.
• Prepares root cause analysis and failure mode and effect analysis (FMEA) for current issues and offers quality enhancing procedures and policies to reduce issues.
• Co-Author of Hazard Analysis for multiple products.
• Coordinates corrective policies for recalls and field actions.
• Evaluates and analyzes product issues related to customer complaints for data elements, trends, risks, and mitigation procedures.
• Reviews compliance issues of both internal and external guidelines.

General Information
• Ability to multitask and manage time in order to perform well on long term projects while being flexible enough to assimilate other projects on an ongoing basis.
• Proficient with PC applications including database, spreadsheet, word processing, and presentations.
• Detailed knowledge of requirements and guidelines and clinical application of those requirements.
• Strong planning, organizing, and interpersonal skills.
• Over 19 years of medical device experience in quality, risk, and product management.
• Clinical nursing experience includes the Emergency Department, CCU, and Pacemaker Clinic.

PROFESSIONAL EXPERIENCE

Smiths Medical – St. Paul, Minnesota
Sr. Clinical Resource Specialist
2008 – 2012
Smiths Medical is a global medical device company for the hospital, emergency, home and specialist environments. Products are used during critical and intensive care, surgery, post-operative care during recovery, and in a series of high-end home infusion therapies.

Boston Scientific / Guidant – St. Paul, Minnesota
Product Manager, LATITUDE Operations
2005 – 2008
Boston Scientific is a global leader in the development and innovation of cardiology, rhythm, and vascular products. Cardiac Rhythm Management includes products that treat irregular heart rhythms, sudden cardiac arrest, and heart failure.

Desert Cardiology Center – Rancho Mirage, California
Supervisor, Pacemaker Clinic
2002 – 2005
Desert Cardiology is the largest private practice cardiology group in the Coachella Valley. It is comprised of fourteen cardiologists, including interventional, electrophysiologists, nuclear medicine, and echocardiography.

Michigan Heart and Vascular Institute – Ypsilanti, Michigan
Sr. Pacemaker Nurse Specialist
1999 – 2002
Michigan Heart and Vascular Institute is a leader in comprehensive cardiovascular care. It is comprised of thirty-four cardiologists, including, interventional, electrophysiologists, nuclear medicine, echocardiography, heart failure, and valvular disease.

University of Michigan Medical Center - Ann Arbor, Michigan
Charge Nurse, Cardiology Units
1993 – 1998
University of Michigan Medical Center is a top ranked medical institution; providing education, patient care, and research.

EDUCATION

Registered Nursing License – Active in California and Minnesota
Bachelor’s in Science, Nursing, 2012, Chamberlain School of Nursing
Graduate courses toward MBA, University of Michigan, Ann Arbor, Michigan
Associate in Science, Nursing, Pasadena City College, Pasadena California
International Board of Heart Rhythm Exam, TESTAMUR NASPExAM/AP/Pacing – 2003, International License
Certified Legal Nurse ConsultantCM (CLNC®) – 2009, Vickie Milazzo Institute