Alexandra Gerhards
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Alexandra Gerhards Email & Phone Number

Manager of Quality - Suppliers and Sustaining at Paragon 28
Location: Denver, Colorado, United States 7 work roles 2 schools
1 work email found @rqteam.com LinkedIn matched
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Current company
Paragon 28
Role
Manager of Quality - Suppliers and Sustaining
Location
Denver, Colorado, United States
Company size
344 employees

Who is Alexandra Gerhards? Overview

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Quick answer

Alexandra Gerhards is listed as Manager of Quality - Suppliers and Sustaining at Paragon 28, a company with 344 employees, based in Denver, Colorado, United States. AeroLeads shows a work email signal at rqteam.com and a matched LinkedIn profile for Alexandra Gerhards.

Alexandra Gerhards previously worked as Associate Manager of Quality - Suppliers and Sustaining at Paragon 28 and Sr. Supplier Quality Engineer at Paragon 28. Alexandra Gerhards holds Chemical And Biochemical Engineering, Biochemical Engineering from Colorado School Of Mines.

Company email context

Email format at Paragon 28

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{first_initial}{last}@rqteam.com
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Profile bio

About Alexandra Gerhards

Alexandra has a BS in Biochemical and Chemical Engineering and has her ISO 13485:2016 Lead Auditor Certification. Alexandra has worked in the medical device industry since 2015 as a consultant supporting medical device manufacturers in device design, quality assurance, and regulatory support. She has been a team member developing 510(k)s and technical files as a contributor on the technical, risk, and substantial equivalency topics. She has conducted Quality System gap assessments and internal audits and has supported and represented clients in multiple notified body audits. Alexandra has also designed and conducted IQ/OQ/PQs to support process validation. Alexandra’s most experience is in Design Assurance where she assists her clients from Design Controls through Design Transfer. She has experience in risk management, contributing to the design and development of new products particularly in requirements, device classification, regulatory pathways, Verification and Validation, and traceability. She has worked with CAPAs, participated in remediation, and conducted QMS training.

Listed skills include Data Analysis, Research, Microsoft Office, Microsoft Excel, and 11 others.

Current workplace

Alexandra Gerhards's current company

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Paragon 28
Paragon 28
Manager of Quality - Suppliers and Sustaining
englewood, colorado, united states
Website
paragon28.com
Employees
344
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7 roles

Alexandra Gerhards work experience

A career timeline built from the work history available for this profile.

Manager Of Quality - Suppliers And Sustaining

Paragon 28

Denver, CO, US

Associate Manager Of Quality - Suppliers And Sustaining

Paragon 28

Sr. Supplier Quality Engineer

Paragon 28

Denver, Colorado, United States

Jul 2023 - Aug 2024

Engineer

Rqm+

Denver, Colorado

Alexandra helps to provide clients with industry-leading regulatory and quality consulting and engineering services throughout the entire product life-cycle. The solutions R&Q provides aim to accelerate the success of medical device companies and improve people’s lives. Alexandra, as a part of the R&Q team, can help clients both small and large with.

Oct 2019 - Jul 2023

Quality And Regulatory Engineer, Project Lead, Project Engineer

Boulder Iq - Innovation To Quality

Boulder, CO

  • Develop regulatory pathways (FDA, EU) including classification, submission pathway, and applicable standards and guidances
  • Put together regulatory submissions including FDA Q-Sub, 510(k), IDE, and EU Technical Documentation
  • Perform internal audits for company and clients (ISO 13485:2016 Lead Auditor certified); implement QMS procedures and processes; remediate non-conformances and deficiencies; aid in and act as company liaison for.
  • Generate non-conforming product reports; investigate failures and determine risk for disposition; generate corrective and preventive action reports; perform failure analysis and determine containment, correction, and.
  • Aid in initial QMS training; train applicable employees on specific process and projects
  • Lead project team to a common goal; manage cross-functional team (including internal and client personnel)
Apr 2015 - Oct 2019

Math/Science/Study Skills Tutor

Sylvan Learning

Broomfield, CO

Teach and guide students through reading, math, and study skills lessons; motivate students to succeed; track student progress; prepare students for the math and science sections of the SAT and ACT standardized tests; and provide homework help for math (primarily high school level), chemistry, and physics areas.

Feb 2015 - Oct 2019

Admissions Clerk

Colorado School Of Mines

Set up applications for review, send out decision letters, help organize promotional events for prospective students, help track fees paid by prospective students, as well as other required tasks.

Sep 2010 - May 2014
Team & coworkers

Colleagues at Paragon 28

Other employees you can reach at paragon28.com. View company contacts for 344 employees →

KR Kevin Rice Kevin Rice Colleague at Paragon 28 Aurora, Colorado, United States, United States View → JV Judithe Van Den Berg Judithe Van Den Berg Colleague at Paragon 28 City Of Johannesburg, Gauteng, South Africa, South Africa View → DD Drew Dyson Drew Dyson Colleague at Paragon 28 Golden, Colorado, United States, United States View → GB Gerel Bazar Gerel Bazar Colleague at Paragon 28 Denver Metropolitan Area, United States View → CR Carolin Reuter Carolin Reuter Colleague at Paragon 28 Denver, Colorado, United States, United States View → NE Nick Elslager Nick Elslager Colleague at Paragon 28 Gilbert, Arizona, United States, United States View → MP Michela Poli Michela Poli Colleague at Paragon 28 Verona, Veneto, Italy, Italy View → RH Relene Harmon Relene Harmon Colleague at Paragon 28 Colorado Springs, Colorado, United States, United States View → NP Nicholas Pinheiro Nicholas Pinheiro Colleague at Paragon 28 Des Moines Metropolitan Area, United States View → PM Philipp Münger Philipp Münger Colleague at Paragon 28 Zurich, Zurich, Switzerland, Switzerland View →
2 education records

Alexandra Gerhards education

Chemical And Biochemical Engineering, Biochemical Engineering

Colorado School Of Mines

Activities and Societies: Sigma Kappa Sorority, Up 'til Dawn, Society of Women Engineers, AIChEBS Chemical and Biochemical Engineering.

Education record

Legacy High School
FAQ

Frequently asked questions about Alexandra Gerhards

Quick answers generated from the profile data available on this page.

What company does Alexandra Gerhards work for?

Alexandra Gerhards works for Paragon 28.

What is Alexandra Gerhards's role at Paragon 28?

Alexandra Gerhards is listed as Manager of Quality - Suppliers and Sustaining at Paragon 28.

What is Alexandra Gerhards's email address?

AeroLeads has found 1 work email signal at @rqteam.com for Alexandra Gerhards at Paragon 28.

Where is Alexandra Gerhards based?

Alexandra Gerhards is based in Denver, Colorado, United States while working with Paragon 28.

What companies has Alexandra Gerhards worked for?

Alexandra Gerhards has worked for Paragon 28, Rqm+, Boulder Iq - Innovation To Quality, Sylvan Learning, and Colorado School Of Mines.

Who are Alexandra Gerhards's colleagues at Paragon 28?

Alexandra Gerhards's colleagues at Paragon 28 include Kevin Rice, Judithe Van Den Berg, Drew Dyson, Gerel Bazar, and Carolin Reuter.

How can I contact Alexandra Gerhards?

You can use AeroLeads to view verified contact signals for Alexandra Gerhards at Paragon 28, including work email, phone, and LinkedIn data when available.

What schools did Alexandra Gerhards attend?

Alexandra Gerhards holds Chemical And Biochemical Engineering, Biochemical Engineering from Colorado School Of Mines.

What skills is Alexandra Gerhards known for?

Alexandra Gerhards is listed with skills including Data Analysis, Research, Microsoft Office, Microsoft Excel, Powerpoint, Microsoft Word, Statistics, and Teamwork.

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