Introduction - Hello Everyone

My name is Maxx Chambers, I am 52 years old and I currently work in Ruskin Florida as a Quality Manager for a Medical Device Class 1 manufacturer.

  • What is your level of quality experience (e.g., new to quality, mid-career, advanced)?
    • I have over 25 Years of experience in Quality Management System deployments and Continuous Improvement Projects.
  • What industry are you in (e.g., manufacturing, healthcare, service)?
    • I am currently in the Medical Device Manufacturing Industry. However I have worked in several industry sectors in the past such as, DOD, Pharmaceutical, Automotive, Aerospace, and Metal Manufacturing Industry.
  • What's a challenge you're tackling or question you're thinking through right now?
    • I have recently been hired as the Quality Manager to a new company.
    • The company has been very successful in the past 40 years without a QMS system.
    • The current challenge is their customers are now demanding that we become ISO 13485 and or ISO 9001.
    • The owner is very very old school and is opposed to having an auditor enter his warehouses for evaluation. (Proprietary reasons)…..
  • Who do you hope to meet by joining myASQ
    • I would like to gather some insight knowledge on how to implement a Quality Management System for the 1st time to an organization that really does not honor or see the value. They have failed several customer audits in the past, (ISO 13485).
    • I am recommending they start off with obtaining a ISO 9001:2015 approach and slowly educate the company on the value of having a QMS. An adopting a new company culture towards Quality. Any information or materials you can provide to help me would be greatly appreciated.
    • I am training the executive management now on the value of understanding SIPOCs and SWOTs. I have alot of work ahead of me……….(Please help).