Guardian Departments
Guardian Positions
GM's Quality Objectives
Customers
Guardian Facts
100

What department coordinates LinkedIn posts, our website, and Trade Show activities? 

What is the Marketing Department

100

What positions are trained on Assembly, Labeling, Shrink Sleeving, and/or receiving Implants.

What is Production 

100

What is the policy called that hangs in the front hallway? 

What is the Quality Policy

100

What customer was the 1 Millionth package?

Who is In2Bones/ ConMed

100

What Year did Guardian ship the first packages? 

What is 2019

200

This Department handles:

  • Customer DMR and Document onboarding

  • Customer Cleaning and Sterilization Validations

  • Equipment and Process Validations

What is a Engineering

200

What position processes payroll and employee onboarding? 

Who is HR/Office Manager
200

How many days (on average) does GM allow NCRs to be closed within?

What is 30 Days

200

This customer purchases Kits that are shipped to two different contract packagers (RMS and QTS).

Who is SI-Bone

200

What is Guardian's Sealing Technology called?

What is CapSure

300

What department processes NCRs, CAPAs, Deviations, and production CofCs?

What is the Quality Department

300
Who can complete a final inspection on product?

Who are Quality Techs and Quality Engineers.

300

How many days (on average) does GM allow for CAPAs to be closed within? 

What is 45 Days

300

This customer ships their packaged product to Japan and was Guardian's first customer.

Who is NuVasive (now Globus)

300

How many Cleanrooms does Guardian have on site?

What is 5

400

What department handles physical product from receiving acceptance through final acceptance and shipping? 

What is the Production Department
400

What position:

  • Engages with potential customers to understand their needs / challenges and offer solutions Guardians CapSure technology or services can provide
  • Issue quotations and participate in final negotiations

What is a Business Development Engineer / Sales 

400

What type of Audit is Guardian required to complete each year?

What is Internal Quality Audit

400
This customer was the first to launch in the Jars.

Who is NanoHive

400

Which ISO standard is Guardian's QMS certified under?

What is ISO 13485

500

This Department:

- Processes Orders for Customers depending on current inventory 

- Places orders for Guardian

- Talks through order details with customers & vendors

What is Purchasing

500

What position manages production from Receiving to Shipping - and makes awesome pancakes?  

What is our Production Supervisor

500

What size of microns need to stay below the specification limits when testing particle counts in the cleanrooms? 

What is 0.5 microns
500

This customer uses a contract packager in Indiana and uses the Valkyrie Packaging system.

Who is ATEC

500

Which ISO standard specifically addresses Guardian's packaging system for terminally sterilized medical devices?

What is ISO 11607

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