Quality Engineer II - Liquid Media
Becton Dickinson
Quality Engineer II supporting liquid media manufacturing operations at Waters Corporation (formerly BD Biosciences). Develops quality procedures, executes validation activities, analyzes quality data, and partners with cross-functional teams to ensure compliance with FDA and ISO standards.
Responsibilities
- Develop and maintain Quality System procedures, SOPs, and policies
- Lead validation activities including change validations and equipment qualifications for media plants
- Monitor and analyze quality indicators for materials, products, and distributed components
- Initiate and support corrective and preventive actions with root cause analysis
- Partner with manufacturing and engineering teams on product launches and process improvements
Requirements
- Bachelor's degree in Biological Sciences, Chemistry, or related science field
- 2 years experience in Quality or Engineering roles
- Moderate knowledge of FDA 21 CFR 820 and ISO 13485/14971 standards
- Statistical analysis and process control skills (SPC, Six Sigma, root cause analysis)
- Ability to manage multiple tasks and execute change management plans
- Technical writing and process/test method validation experience preferred
Vacancy posted more than 2 months ago
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