Specialist, Quality Complaint Investigation
On-site · San Ġwann, Saint John, Malta
Job Summary
Specialist, Quality Complaint Investigation responsible for investigation, review, and completion of Quality Engineering complaint issue analysis tasks using quality system inputs (e.g., FCA, MDR, FDA). Analyze data to determine trends and root causes, prepare and issue analysis reports, identify gaps for GMP compliance, develop strategies to close gaps, communicate expectations for quality performance and continuous improvement, and support CAPA and maintenance activities for existing product lines. Requires a Bachelor’s degree in Engineering and 1-3 years of Medical Device experience; knowledge of FDA cGMP and 21 CFR 820 preferred.
Required Qualifications
- Bachelor’s degree in Engineering
- 1-3 years of Medical Device experience
- Medical Device Experience with knowledge of 21CFR820 preferred
- Investigational research skills
- Experience with statistical software (Minitab a plus)
- Knowledge of FDA cGMP; ANSI/ISO/ASQC requirements; CMDAS (optional)
- Reading and understanding blueprints/technical drawings
- Strong analytical problem solving (Root Cause Investigations)
- CAD or scheduling tasks using software-based tools
- Proficiency with Word, Excel, PowerPoint, Minitab, Access and databases
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