Boddingtons continues to invest in systems of quality and quality assurance that differentiate it from the pack. For example, the company has attained the new MDSAP (Medical Device Single Audit Program) having qualified for the new standard at the first time of asking.
MDSAP is a global regulatory audit approach promoting alignment of Quality Management Systems and Regulatory approaches with the goal of improving medical device safety.
We talked to new recruit Greg Maruszak about his work in relation to this and other areas of work at the company.
Greg – welcome to the Boddingtons website blog. You have diplomas and first degrees in electronics, digital systems, computing and technology. Has that assisted your work in the Quality Department at Boddingtons?
Yes I would say that it has. So much work now involves an understanding of computing and electronics and that education together with previous industrial experience in medical and also aerospace has been very helpful in relation to my work today.
And Boddingtons supplemented that skillset with further training?
Yes. Right away Boddingtons sponsored some very specific training from the initial Company Induction, updates on ISO 13485, and then more job specific training such as Internal Audit skills, Training on Boddingtons measurement equipment, External Mitutoyo-specific training courses and then general Boddingtons processes and other kinds of knowledge and skills. There is a lot to learn – and also much to apply in our ongoing workload.
Greg Maruszak – Quality Engineer
How does that know-how pan out for you – day to day?
A typical day might begin with some over-checking of the production paperwork from the previous day, including the inspection of the last off’s samples.
Another part of the job includes the validation of the medical and non-medical new parts in order to proof that our processes are stable and repeatable. Boddingtons has a very flexible approach due to the sectors that we work within, so anything from generating ISIR’s (Measurement Reports) through to full validation (IQ,OQ,PQ) is covered and supported.
The validation involves measuring parts with Vernier Callipers, CMM and Vision Systems and then analysing the data we create to ascertain that we are statistically stable via the generation graphs and charts .
I am also responsible for Environmental Monitoring for our Cleanroom Class 7. Another part of the work is the review and approval of the external certificates for all our various production materials.
It sounds quite diverse?
It certainly is – and that provides part of the enjoyment, day to day. Most of the time you are working to effectively balance all of these tasks in order to get the most efficiency and effectiveness out of the day. It’s also a great help to have friendly co-workers and a great working atmosphere in which to get the job done.
Why does Quality matter so much at Boddingtons?
Quality is our key focus and is underpinned by a culture of continuous improvement. Our goal is to minimise risk and achieve outstanding quality and consistency of product delivered on time to our customers.
And what’s next for Greg at Boddingtons?
As measurement is so key to everything we do, I’m looking to enhance what I have learned and am gaining more experience with the measuring equipment including programming of our CMM and Vision Systems.