Interview with Lois OwenQuality Systems Engineer at Siemens Healthineers Llanberis

Lois Owen

My main duties involve: ensuring compliance with ISO 13485, FDA 21 CFR Part 820 and other international Regulatory requirements, making certain that business needs are met through the delivery and operation of vigilance and post market activities, internal and external audits and the CAPA system.

After completing a Degree in Biomedical Science in Bangor University, my initial goal was to be a scientist. I had a young family after finishing University, so getting a job in a company like Siemens was perfect for me – being local to where I live was another plus! I began in my first role as a Technician in Technical Operations in late 2010, progressing to a Scientist in early 2013. I have now transitioned to Quality Systems Engineer within the Quality Management department.

What does your typical working day look like?

A typical working day for me includes:

  • Responding to emails
  • Reviewing CAPA’s and issue resolutions
  • Reviewing internal audit reports
  • Reviewing Medical Device Vigilance reports
  • Preparing for external Audits

  • Preparing data for CAPA
  • Audit and Management Review Boards
  • Sitting on Escalation Review Council’s Product Quality Committee’s
  • Raising Product holds

Knowing that the end customer, the patients, are benefitting from our products. We all know someone who’s been affected by an illness in their lives, so knowing that what we produce can save lives is an incredibly powerful driver in the way we all work at Llanberis.

Ensuring that we produce the highest quality product for our customers is a key part of my role. Ensuring that we meet CAPA and Audit timelines is key to our product quality. Our customers are relying on corrective actions to be in place if any issue occurs in the field or during the manufacture of our products.

I would say ‘go for it’. My colleagues are friendly and outgoing and there’s a great social aspect here if you want it. There are many opportunities for career progression – you just need to voice it and work for it.

Friendly, focused, driven, committed and united.

Don’t let anyone put you off from having a career in Science or Engineering, especially for the girls!