Training for your team, and mentoring for quality managers
Compliance is a team sport, and I help your people play it well. I train teams on ISO 13485, QMSR, EU MDR, EU IVDR and MDSAP, and mentor quality managers who carry the role on their own.
Three situations where this works best
New employees, or a team that has never worked under a quality system, need to understand what is required and why.
A new regulation, a new edition of a standard or a new process means the team has to learn it.
She carries the entire system alone and wants someone senior to think it through with.
Your team needs the basics
Something changed
Your quality manager works alone
Your team sees quality as paperwork rather than part of the work.
An auditor found that training records don't match what people know.
Your QA/RA manager is new to the role.
You are preparing the team for its first audit.
You want training built around your own procedures.
You probably need this if one of these sounds familiar
A team that understands the requirements
Around your device, your procedures and the questions your team really has.
Regular sessions with your quality manager on the issues on their desk.
Interactive training material from learn., my training site.
People who understand the requirements and can apply them without me.
Training built for your team
Mentoring
Practical material
A team that can carry the system
From a first conversation to the work itself
You tell me about the device, the market you are aiming for and your timelines. I tell you what I would do first.
When needed, I go through your procedures, your technical file or your most recent audit reports.
The scope of work, estimated hours and a timeline. I work by the hour.
I work with your team on what the company needs at that stage, and we meet regularly for updates.
A first conversation
Looking at what you have
A clear proposal
The work itself
At one of the companies I work with, I run training sessions for the team on a range of quality and regulatory topics. I also build courses on learn., my training platform. In the Quality Queens community, I run the StepP Up Academy, which offers professional webinars, round tables and masterclasses. I'm also a mentor in the community's Quality Leadership program, which I sponsor as well.
Training inside companies and in the community
Both. I can be your QA/RA manager, or work alongside the QA/RA manager and team you already have.
Both are possible. Many clients start with a project and continue with a few hours a month of ongoing support. I work by the hour, and offer a fixed price only when the scope is closed and known in advance.
It depends on the scope. I work by the hour, and after a first conversation, and sometimes a look at what you already have, I send a proposal with the scope, estimated hours and timeline.
Can you support an existing team, or only work as the sole QA/RA resource?
How do engagements typically work – project-based or ongoing?
How much does it cost?
Related articles
A 30-minute call. You tell me where you are, I tell you what I'd do first and whether I'm the right fit.