Staff Design Quality Engineer
SCIPRO LTD.
Brisbane, United States of America
yesterday
Role details
Contract type
Permanent contract Employment type
Full-time (> 32 hours) Working hours
Regular working hours Languages
English Experience level
SeniorJob location
Brisbane, United States of America
Tech stack
Failure Mode Effects Analysis
Minitab
JMP (Statistical Software)
Test Scripts
Job description
- Ensure all design control activities for new and updated products meet company procedures and global regulatory requirements.
- Lead risk management activities, including hazard analysis, FMEAs, and risk documentation.
- Support sterilization and biocompatibility assessments.
- Own and maintain design control documentation.
- Partner with R&D, Regulatory, Manufacturing, and Project Management to ensure quality is built into every stage of product development.
- Maintain accurate test, validation, and risk records and report progress to leadership.
- Support regulatory submissions (e.g., 510(k), CE Mark).
- Lead root cause investigations and corrective actions related to design issues.
- Support complaint investigations, nonconformances, and CAPAs after product launch.
- Conduct DHF audits to ensure phase completion requirements are met.
- Review and approve engineering documents and test reports.
- Identify opportunities to improve product quality, reduce cost, and increase efficiency.
Requirements
- Bachelor's degree in Engineering or related field.
- 10+ years of quality engineering experience in medical devices, including new product launches.
- Experience with sterilization and biocompatability
- Strong knowledge of design controls, risk management, and medical device regulations (FDA, ISO, IEC).
- Experience with verification & validation (V&V) and FMEAs.
- Strong problem-solving and statistical analysis skills (e.g., Minitab, JMP).
- Detail-oriented with strong documentation skills.
- Quality certifications (CQE, CSQE, Six Sigma) are a plus.
