By education, I am a Biomedical Engineer in both my undergraduate and graduate degrees. When I was working as a Biomedical Engineer, I learned that being able to resolves issues with exact information is more important that being smart and knowing about everything. As a Biomedical Engineer, at times it felt like you are and have to be Jack of all trades but you end of being Master of none. This is not because of the lack of capability but because every issue, every problem required us to stretch beyond one specialty. When I had communications with medical doctors, I was being communicated as an Engineer and when I talked to Engineer, I was referred to as Biomedical. When I graduated, I was one of the first hundred Biomedical Engineers in the country. It sounded prestigious. It felt terrifying. There were few opportunities, fewer mentors, and absolutely no roadmap. I didn’t know it then, but that exact uncertainty would prepare me for QA better than any course ever could.
When working as a QA, there is this similar scenario of being Jack of all traders but Master of None. First couple of months is about understanding the application and its legacy, then comes the fun part identifying the issues and reporting them. But slowly, and quietly, the role started expanding without me knowing.
Nobody tells you to:
- You'll have to understand risk management.
- You'll eventually write automation scripts.
- You'll reverse engineer algorithms.
- You'll learn SQL management, ML behavior, performance benchmarking.
- You'll get pulled into regulatory compliance and safety analysis.
- You'll run UAT sessions with clinicians, auditors, engineers and vendors.
- You'll be the main gatekeeper before application goes to actual users.
In fact, I was repeatedly told:
- Oh QAs don't need coding, it's just a nice to have.
- You don't need the learn Risk Management Frameworks, it's for QMS team.
- You don’t need deep analytics.
- Don't worry about User Experience, it's for Product Managers and Business Analysts.
I am so happy, I didn't listen. Curiosity changed everything.
- It is actually very important for us to not just care about how to make the applications fail and in what workflow, but to understand why things fail.
- Working with medical devices forced me to understand the impact of failures on people's life. Understanding the Risk got more and more meaningful with Iso 13485, ISO 14971 and MDR applications.
- Working with repeated testing with so many scenarios, so many datasets, so many repeated calculations, led me to develop my automation frameworks for validation of ML algorithms, and even reverse-engineered the calculations from reverse engineering scientific computations from legacy code.
- Testing on ML algorithms led me grow my horizon by learning and working on segmentation accuracy, performance testing, statistical robustness, content testing with different data providers (device manufacturers), clinical relevance of outputs.
- Even at some points, I was writing, reviewing, and tracing test protocols, QMS documents, risk files, MDR gap assessments, FDA/Health Canada expectations, CAPA investigations, internal audits and so much more.
The list goes on and on. Did I went through Biomedical Engineering studies to become a QA, no I did not but I grew with my experience, my passion. To understand this better is the source of my current skills not job descriptions, not requirements and not of course not any expectations from my seniors.
Yes, it was not a planned decision but I stayed because I grew with it and I grew into it. This is the profession that rewards curiosity, patience, precision, cross-disciplinary thinking, stubbornness and it gives us the strength to refuse to accept shallow answers. This is the field where learning doesn't end and I am still learning more and more every day.