Analytical test method validation (gpc, hplc, ftir)
High volume manufacturing in regulated industry
You will support Dexcom in launching state-of-the-art innovative technology and will help define, support, and improve the processes that get us there
Job Summary
You will support Dexcom in launching state-of-the-art innovative technology and will help define, support, and improve the processes that get us there.
You provide leadership and technical guidance for strengthening of and adherence to the Quality Management System (Failure Model Effects Analysis (FMEA), qualification and validation requirements, CAPAs, NCMRs, Process Controls).
You create strong partnerships with R&D, Regulatory Affairs, Customer Advocacy, Process Engineering, Manufacturing, Equipment Engineering, Maintenance teams and more.
Matching Summary
You will support Dexcom in launching state-of-the-art innovative technology and will help define, support, and improve the processes that get us there.
Salary
$111,100.00 - $185,100.00
Skills & Requirements
Must-have
Chemistry, polymers/polymer manufacturing
Analytical test method validation (GPC, HPLC, FTIR)
High volume manufacturing in regulated industry
Quality Management System (QMS) leadership
Risk-based decision-making
Root cause analysis, Six Sigma, structured problem solving
Nice-to-have
Strategic work with minimal direction
Cross-functional and international alignment
Partnerships with R&D, Regulatory Affairs, Manufacturing
Passion to improve systems and processes
Inquisitive, investigative, detailed approach
Key Requirements
Bachelor’s degree in technical discipline or equivalent experience
8-12 years related experience (Bachelor's)
Familiarity with Medical Device regulations (21 CFR 4, 10, 11, 820, USP, ISO 13485, EU MDR)
Six Sigma, Lean manufacturing experience
Statistical data analysis, sampling plan development, sample size determination