Work Preference
Summary
Overview
Work History
Education
Skills
Timeline
Generic
Amber Knapp
Open To Work
Verified
This profile is verified using an email address.

Amber Knapp

Littleton,CO

Work Preference

Job Search Status

Open to work
Desired start date: Open to discussion

Work Type

Full TimePart TimeContract WorkGig WorkConsultingVolunteerSeasonal Work

Location Preference

RemoteHybrid
Location: Littleton, CO, USDenver, COWheat Ridge, COGolden, COHighlands Ranch, CO
Open to relocation: No

Important To Me

Company CultureCareer advancementWork-life balanceWork from home option

Summary

Experienced Quality Management Consultant specializing in operational efficiency and regulatory compliance in the medical technology sector. Navigates global standards and implements strategic roadmaps to enhance quality and reduce costs. Drives transformative initiatives that align with organizational objectives and industry regulations.

Overview

12
12
years of professional experience

Work History

Senior Consultant

Veeva
Denver, Colorado
2026.01 - Current
  • Analyzed client needs to design and implement customized software strategies and workflows, enhancing alignment with business goals.
  • Facilitated workshops to gather requirements and align project objectives with stakeholders, ensuring clarity and shared vision.
  • Managed project timelines and resources to ensure adherence to client specifications.
  • Developed training materials and conducted sessions for client staff on system usage, improving user adoption and proficiency.
  • Collaborated with product development teams to enhance software features based on feedback.

MDR Vigilance Manager

Medtronic
2025.01 - 2025.12
  • Partnered with senior leaders to align quality strategies with organizational objectives, presenting data-driven recommendations and execution plans.
  • Led cross-functional improvement initiatives in complaint handling and quality operations using Lean Six Sigma, resulting in reduced cycle times and improved customer outcomes.
  • Analyzed performance metrics, identified gaps, and implemented scalable solutions to enhance workflow efficiency.
  • Managed and developed remote teams across Minnesota and Galway, Ireland, fostering a culture of accountability and collaboration.

Senior MDR/Vigilance Supervisor

Medtronic
2021.12 - 2025.01
  • Led cross-functional automation initiatives that increased productivity and lowered operational costs by 20%.
  • Restructured operational workflows to enhance quality KPIs by 26% within two quarters.
  • Developed and presented compliance and quality metrics to senior leadership, supporting informed decision-making and prioritization.

Senior MDR/Vigilance Specialist – Team Lead

Medtronic
2019.09 - 2021.12
  • Served as SME for adverse event reporting, enhancing accuracy and timeliness for US FDA, EU, and Health Canada and fostering cross-functional communication.
  • Implemented Cell Operating Systems for complaint handling, increasing productivity by 118% and standardizing processes to enhance regulatory compliance.
  • Collaborated with regulatory authorities, customers, and internal stakeholders to resolve compliance concerns and fulfill audit requests.

MDR/Vigilance Specialist

Medtronic
Mounds View, USA
2014.11 - 2019.09
  • Managed regulatory inquiries from US FDA and OUS competent authorities for Cardiac Rhythm Management business unit, ensuring compliance and timely responses that enhanced product safety.
  • Analyzed quality data to identify trends and implement quality improvement measures that proactively addressed potential issues.
  • Developed training materials for new staff onboarding processes.

Education

Bachelor of Science - Psychology and Biology

University of Minnesota, Twin Cities
Minneapolis, MN
2012-01

Skills

  • Problem Solving
  • Strategic Planning
  • DMAIC/Lean Six Sigma
  • Leadership
  • Coaching
  • Project management
  • Analytical Thinking
  • Regulatory compliance
  • Process Optimization
  • Data Analytics
  • Business Analysis

Timeline

Senior Consultant

Veeva
2026.01 - Current

MDR Vigilance Manager

Medtronic
2025.01 - 2025.12

Senior MDR/Vigilance Supervisor

Medtronic
2021.12 - 2025.01

Senior MDR/Vigilance Specialist – Team Lead

Medtronic
2019.09 - 2021.12

MDR/Vigilance Specialist

Medtronic
2014.11 - 2019.09

Bachelor of Science - Psychology and Biology

University of Minnesota, Twin Cities

Similar Profiles

CREATE PROFILE
Amber Knapp