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About the role
Key responsibilities & impact- Perform systematic reviews of quality records to ensure accuracy and compliance
- Utilise statistical analysis to create control charts and analyse quality data trends
- Monitor complaint data to identify emerging trends and potential systemic risks
- Respond to internal and external requests for quality-related data
Requirements
What you’ll need- Master’s degree in a technical or scientific field preferred
- 3-5 years of experience in post-market surveillance, complaints, quality engineering
- Advanced knowledge of post-market surveillance and product risk assessment
- Familiarity with regulatory standards: EU MDR, 21 CFR 820, ISO 13485, ISO 14971
- Advanced skills in Excel and Minitab
- Certification in Quality Management Systems (e.g., ISO 13485, ISO 9001, ASQ, Lead Auditor) desirable
- Statistical Analysis certification
- Six Sigma Green or Black Belt certification desirable
Benefits
Comp & perks- Paid time off
- Flexible work arrangements
- Professional development opportunities
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
statistical analysiscontrol chartsquality data analysispost-market surveillanceproduct risk assessmentExcelMinitab
Certifications
Quality Management SystemsISO 13485ISO 9001ASQLead AuditorStatistical Analysis certificationSix Sigma Green BeltSix Sigma Black Belt