I've been in a quality management role for close to five years now. I work for a small business (around 40 employees) in the medical devices industry.
I would have to say that my biggest challenge in this role has been to try and promote the idea that the processes put in place for our QMS are not just "bureaucracy." When I started in my current role, I was tasked with implementing a QMS and gaining our certification to ISO 9001:2015. I quickly learned that the hardest part of these tasks would be trying to change the culture of the company. Processes that seemed to me to be commonsense needs of a thriving QMS would be shot down as being unnecessary, too much paperwork, etc. To employees and even some members of the management team, anything that was done related to the QMS was done "for ISO." People preferred to do the bare minimum; they wanted to only do what would meet the minimum requirements of our registrar so we could have the certificate on the wall.
I am happy to say that our culture has significantly changed in the last five years. We just recently finished our re-certification audit to start our fourth year as a company certified to ISO 9001:2015. However, we still have to work to continually improve company culture in regard to quality every day. I've learned that you can implement processes all day, but if employees don't believe in them, then truly they do just become bureaucracy.
I'm looking forward to learning from my peers in the ASQ community!