Manager leading R&D quality assurance for Apotex, a Canadian global health company developing affordable medicines. Overseeing GMP compliance, batch disposition, investigations, audits, and QA staff.
About the role
- Systems Quality Engineer investigating software, systems, and hardware interaction issues for Kardium’s atrial fibrillation medical device. Driving root-cause analysis and product reliability improvements.
Responsibilities
- Perform and document technical investigations into product feedback and complaints, focusing on software, system, and hardware/software interaction issues
- Review system recordings, log and configuration files, software logic, and product requirements to determine whether the system behaved as intended
- Characterize reported issues, identify trends, and assess potential product risks
- Perform root-cause investigations and translate findings into recommendations to improve product performance and reliability
- Partner with Engineering, Manufacturing, Test, Quality Engineering, Risk Management, and subject matter experts to evaluate technical evidence and support investigation conclusions
- Develop scripts or data analysis tools to support investigations, assess system performance, and analyze large technical datasets
Requirements
- Bachelor’s degree in Software, Mechatronics, Electrical, Biomedical Engineering, or a related engineering field
- Minimum 5 years’ experience in software, systems, design, or quality engineering
- Ideally experience in medical devices or another regulated, high-reliability industry
- Hands-on experience investigating complex software or system-level issues using technical evidence to assess product behaviour against requirements
- Practical experience with programming, scripting, or data analysis using MATLAB, Java, C, or similar languages
- Working knowledge of electrical signals, electrical design principles, and electrical failure modes
- Strong written and verbal technical communication skills
- Ability to create clear documentation and share technical information effectively
- Ability to work collaboratively with cross-functional teams and subject matter experts
- Ability to work independently and as part of a team
Benefits
- Retirement Savings Plan contribution included in total cash compensation
- Stock option plan for permanent employees
- Comprehensive medical and dental coverage effective Day 1 with no waiting period
- Flexible work environment for daily working hours
- 3 personal days per year
- Well-being support for employees and dependents
- Maternity, adoptive, and parental leave top-up
- Fertility drug treatment benefit coverage
- Career progression and learning support
- Professional membership support
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