Software Quality Engineer III
Our client is a global medical technology company dedicated to transforming lives through innovative solutions that improve patient health. They design and manufacture a wide range of minimally invasive medical devices used in areas like cardiology, neurology, urology, and oncology. With over 50,000 employees worldwide, they serve patients in more than 120 countries and are known for its commitment to meaningful innovation, quality, and advancing science for life.
About the Role We're looking for an experienced Software Quality Engineer to join our dynamic Quality team supporting manufacturing, R&D, laboratory, and IT systems. This is a high-impact role focused on ensuring our software and firmware systems meet FDA regulations, customer expectations, and our quality standards across the entire development lifecycle.
What You'll Do
Serve as a key quality voice across cross-functional teams, from product development to operations
Independently review and approve documentation related to software design, testing, and qualification
Ensure thorough verification and validation activities in line with internal policies and FDA guidelines
Evaluate and approve system changes, ensuring compliance and controlled implementation
Apply Good Documentation Practices (GDP) to assess test results and manage discrepancies
Support internal and external audits, CAPAs, and non-conformance investigations
Champion best practices in software QA across teams and departments
Build strong internal relationships to help teams deliver reliable, high-quality systems
Your Background
Bachelor's or higher in Engineering, Computer Science, or related technical field
4+ years of experience in software QA or computer systems validation, ideally within a regulated industry
Strong understanding of SDLC, V&V methodologies, and FDA requirements (21 CFR Part 11)
Skilled at reviewing (not just executing) technical documentation across the QA spectrum
Able to work independently and collaboratively in a fast-paced, detail-critical environment
Excellent organizational and communication skills with a customer-first mindset
Preferred Extras
Experience in the medical device industry or other FDA-regulated sectors
Familiarity with automated manufacturing and lab systems
Working knowledge of PLC and SCADA systems
Strong critical thinking and problem-solving skills with an analytical approach
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your CV and details on file so when we see similar roles or see skillsets that drive growth in organisations, we will always reach out to discuss opportunities.
Yes. Even if this role isnāt a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.
That's why we recommend registering your CV so you can be considered for roles that have yet to be created.
Yes, we help with CV and interview preparation. From customised support on how to optimise your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.