Kim Wallner

Kim Wallner Email and Phone Number

Senior Manager Regulatory Affairs @ Medtronic
Minneapolis, MN
Kim Wallner's Location
Greater Minneapolis-St. Paul Area, United States, United States
Kim Wallner's Contact Details

Kim Wallner work email

Kim Wallner personal email

About Kim Wallner

Kim Wallner is a Senior Manager Regulatory Affairs at Medtronic. He possess expertise in capa, fda, quality system, validation, iso 13485 and 19 more skills. Colleagues describe him as "At Genmab, Kim was highly dedicated with a strong knowledge of GMP quality principles. She successfully applied that knowledge to a variety of situations, and because of that, was well respected both within the department and throughout the company. As her manager, I found that Kim proved to be an independent worker with great initiative, constantly picking up on continuous improvement ideas and carrying them through to successful implementations. I would be honored to work with Kim again and would consider myself lucky to be at the same company." and "Kim is a very talented and experienced Quality professional that can be counted on to meet or exceed all expectations. During my 8-month tenure as Director, Quality Assurance at Genmab, Kim was a valuable and independent contributor of our QA department where she was responsible for supporting all Quality Systems at the facility. Kim was responsible for maintaining and trending the Quality Systems. In addition, her strong microbiology background enabled her to provide QA guidance on many issues related to environmental monitoring and method validation of micro methods. Kim’s strong attention to detail, wide base of experience and mature approach to solving problems ensures you can rely on Kim to deliver excellent results on a consistent and timely basis. Kim made numerous contributions this year, including assisting in the development of a new TrackWise deviation/CAPA system, numerous process improvements in Quality Systems, and independent resolution of complex deviations and CAPAs. I could always count on Kim to provide a thorough analysis and development of solutions to Quality challenges presented to her. I strongly recommend Kim as a QA professional."

Kim Wallner's Current Company Details
Medtronic

Medtronic

View
Senior Manager Regulatory Affairs
Minneapolis, MN
Website:
medtronic.com
Employees:
10
Kim Wallner Work Experience Details
  • Medtronic
    Senior Manager Regulatory Affairs
    Medtronic Jul 2021 - Present
    Minneapolis, Mn, Us
  • Medtronic - Aortic, Peripheral And Venous (Apv)
    Principal Regulatory Affairs Specialist
    Medtronic - Aortic, Peripheral And Venous (Apv) Jan 2016 - Jul 2021
  • Cardiovascular Systems, Inc.
    Sr. Regulatory Affairs Specialist
    Cardiovascular Systems, Inc. Mar 2014 - Dec 2015
    St. Paul, Mn, Us
  • American Medical Systems
    Regulatory Affairs Specialist
    American Medical Systems Jun 2012 - Mar 2014
  • St. Jude Medical
    Senior Quality Systems Engineer
    St. Jude Medical Dec 2009 - Jun 2012
    St. Paul, Minnesota, Us
  • Genmab Mn, Inc. (Formerly Pdl Biopharma)
    Quality Assurance Associate
    Genmab Mn, Inc. (Formerly Pdl Biopharma) Jan 2006 - Dec 2009
    2500 Valby, Dk
  • Paddock Laboratories
    Microbiology Technical Data Auditor
    Paddock Laboratories Jan 2003 - Jan 2006
    Us
  • Paddock Laboratories
    Microbiology Technician Ii
    Paddock Laboratories Sep 2001 - Jan 2003
    Us
  • Part Three
    Microbiologist
    Part Three May 2000 - Sep 2001
    • Performed general microbiological testing on pharmaceutical products
  • Diasorin
    Product Development Technical Specialist
    Diasorin Jul 1996 - May 2000
    Saluggia, Vc, It
    • Assisted in development of immunoassays for the detection of various autoimmune diseases

Kim Wallner Skills

Capa Fda Quality System Validation Iso 13485 Medical Devices V&v Regulatory Affairs Quality Assurance Gmp Design Control Quality Management Iso 14971 Regulatory Requirements Software Documentation Trackwise 21 Cfr Part 11 Process Improvement Remediation Microbiology Regulatory Science Sterilization 21 Cfr Configuration Management

Kim Wallner Education Details

  • University Of Minnesota
    University Of Minnesota
    Microbiology

Frequently Asked Questions about Kim Wallner

What company does Kim Wallner work for?

Kim Wallner works for Medtronic

What is Kim Wallner's role at the current company?

Kim Wallner's current role is Senior Manager Regulatory Affairs.

What is Kim Wallner's email address?

Kim Wallner's email address is kl****@****ail.com

What schools did Kim Wallner attend?

Kim Wallner attended University Of Minnesota.

What skills is Kim Wallner known for?

Kim Wallner has skills like Capa, Fda, Quality System, Validation, Iso 13485, Medical Devices, V&v, Regulatory Affairs, Quality Assurance, Gmp, Design Control, Quality Management.

Who are Kim Wallner's colleagues?

Kim Wallner's colleagues are Jenn Minahan, Ms, Rd, Cdces, Savina Stephanie Saldanha, Daehyun Kim, Luciano Vranjican, Mara Ruiz Muniz, Abraham Acosta, Darren Hanes.

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