Simona Jahnke

Clermont Florida ***** 970-***-****

linkedin.com/in/simonawundtjahnke adct8x@r.postjobfree.com

SENIOR PRODUCT QUALITY ADVOCATE

MEDICAL DEVICE MANUFACTURING - Using SAP complaint handling, lead the clinical analysis associated with medical device complaints, specializing in evaluating and interpreting safety or clinical impact as it relates to complaint reporting, investigations and potential corrective actions. Medical device clinical expert, guiding decision making for Medical Device and Vigilance reporting to ensure adherence to US and International regulations and company’s policies and processes.

EXPERIENCE

MEDTRONIC NAVIGATION – Louisville, CO November 2002 – September 2019

Senior Product Quality Advocate, Quality/Regulatory November 2010 – September 2019

Reviewed and investigated complaints that come through the Technical Services Center.

●Conducted initial reviews and justifications for complaints/MDR’s to be filed with the FDA.

●Delivered support for international representatives with vital information regarding hardware/software status updates.

●Collaborated with risk management, software/hardware teams providing feedback/product expertise needed to make assessments/justifications on reportability.

●Provided front room/back room support for FDA and internal/international, MDSAP, notified body inspections.

●Over 90% of completion rate of Medical Device Reporting within 7 days.

Technical Services Specialist November 2002 – November 2010

Provided telephone based technical support, worked directly with project managers and engineers to develop products, performed system installations, level II troubleshooting, clinical support, surgeon/clinical staff training, and VIP demonstrations.

Educational Support

●Trained field-based personnel, surgeons and hospital staff, domestically and internationally on clinical and technical application of Medtronic products.

Sales and Service Support

●Performed follow-up investigation to fully resolve issues.

●Escalated customer needs when necessary while ensuring documentation is in line with the applicable FDA regulation.

Simona Jahnke

adct8x@r.postjobfree.com

NORTH COLORADO MEDICAL CENTER – Greeley, CO April 1996 – October 2008

Certified Nursing Assistant

Vital, hands on clinical team member for all areas of the maternity ward, including delivery, newborn nursery, neonatal intensive care nursery, surgical cases and maintenance of medical supplies.

Team lead for onboarding of new employees, supervising success and development.

Comforted and cared for families through infant bereavement process.

Provided aid in the operating rooms and ensured patient comfort and care, sterility, and availability of surgical supplies.

DISNEY CRUISE LINE, Cape Canaveral. FL December 2001 – June 2002

Programming Department

●Ensured the safety and entertainment of all guests.

●Presented programs and shows while maintaining an enjoyable environment.

●Assisted new hires in assimilating to the Disney standard.

ADDITIONAL SKILLS

SAP Complaint Handling

(GCH) Global Complaint Handling,

21 (CFR) Code of Federal Regulations 820 – (QSR) Quality System Regulation

21 (CFR) Code of Federal Regulations 803 – Medical Device Reporting

21 (CFR) Code of Federal Regulations 1000-1004 Accidental Radiation Occurrence Reporting

(ISO) International Organization for Standardization 13485 – Quality System

(ISO) International Organization for Standardization 14971 – Risk Management

End-to-End Product Complaint Management

Proficient in all Microsoft Office programs

Salesforce.com

Regulation

EDUCATION

Bachelor of Science (BS) in Biology, University of Northern Colorado Nursing and Pre-Medicine Coursework

CERTIFICATIONS

AvaMed, Code Office Ethics and Compliance

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