Software Design Quality Engineer
SOURCEO PTE. LTD.
9 hours ago
Posted date9 hours ago
N/A
Minimum levelN/A
Human ResourcesJob category
Human ResourcesKey Responsibilities
Required Qualifications
- Support software design quality activities within global product development teams.
- Guide software verification and validation, including test methods, acceptance criteria, and documentation; ensure compliance with IEC 62304.
- Lead software risk management activities and maintain risk files.
- Support software safety, effectiveness, and cybersecurity processes.
- Provide regulatory guidance in collaboration with global Regulatory Affairs; ensure compliance for medical and non-medical products.
- Improve QMS processes based on audits, quality events, or regulatory updates (FDA 21 CFR 820, ISO 13485).
- Support internal audits, CAPA activities, training, and cross-functional quality initiatives.
Required Qualifications
- Bachelor's degree in engineering (Master's preferred).
- 5+ years in quality or regulatory engineering in medical devices or other regulated industries.
- 3+ years focused on software quality/regulation.
- Experience with IEC 62304, software validation, and medical device standards (ISO 13485, 21 CFR 820, ISO 14971).
JOB SUMMARY
Software Design Quality Engineer
SOURCEO PTE. LTD.
Singapore
9 hours ago
N/A
Full-time
Software Design Quality Engineer