Bachelor's degree in biological sciences or chemistry
2+ years experience in quality or engineering
Knowledge of fda 21 cfr 820 and iso 13485/14971
The Quality Engineer II position at Waters Corporation, part of BD, seeks candidates with experience in quality systems in regulated environments, particularly in medical device or pharmaceutical manufacturing. The role emphasizes continuous improvement, process control, and compliance with FDA and ISO standards
Job Summary
This role provides guidance for the various elements of the Quality System to ensure process control and consistent manufacturing practices.
The position involves monitoring quality indicators, assessing Critical To Quality parameters, and leading investigations for corrective actions.
Waters and BD offer a culture that values innovation, collaboration, and supporting associates to learn, grow, and become their best self.
Matching Summary
Match Score: 85
The Quality Engineer II position at Waters Corporation, part of BD, seeks candidates with experience in quality systems in regulated environments, particularly in medical device or pharmaceutical manufacturing. The role emphasizes continuous improvement, process control, and compliance with FDA and ISO standards.
Salary
Base: $73,300.00 - $121,000.00 USD Annual; Bonus/Equity: Not specified; Benefits: Comprehensive Total Rewards program including performance-based culture
Skills & Requirements
Must-have
Bachelor's degree in Biological Sciences or Chemistry
2+ years experience in Quality or Engineering
Knowledge of FDA 21 CFR 820 and ISO 13485/14971
Statistical tools like SPC, Six Sigma, and root cause analysis
Experience with CAPA initiation and investigation
Nice-to-have
Technical writing and validation execution skills
Experience in medical device or pharmaceutical manufacturing
Knowledge of automated filling and packaging systems
Ability to lead change management plans
Strong communication and presentation skills
Key Requirements
Bachelor's degree in related science field
Minimum 2 years of Quality or Engineering experience
On-site presence required (minimum 4 days per week)