The Quality Engineer II is responsible for ensuring consistency and compliance with Quality Systems, using statistical and analytical tools, and working with variable enterprise systems and Corporate directives. The role involves supporting instrument platforms, audits, documentation compliance, and root cause investigations, and requires frequent interaction with other functional areas.
Requirements
- Maintain International Organization for Standardization (ISO) and regional regulatory requirements
- Develop Device History Files and maintain in a manner consistent with regulatory requirements
- Generate process/product quality information in the form of CTQ (Critical to Quality) indices, recommendations and solutions to emerging issues
- Supports the coordinated integration of new products into Manufacturing / Operations
- Ensures BD Diagnostic Systems divisional, departmental policies, procedures, practices and facilities are in compliance with all applicable regulatory policies
- Understanding and coaching others on Quality Systems and procedures
- Perform trend analysis, risk management (such as FMEA, Hazard Analysis, Fault Tree) and six sigma tools
- Cost Center Specific: Skilled in working in a team environment, ability to perform multiple tasks, effectively manage conflict and drive for results with minimal supervision
- Knowledge of GLP/GMP/ISO requirements and sound understanding of the pertinent Quality System/Regulations
- Computer skills in word processing, spreadsheets and a statistical package required. Must have excellent communication skills
- Knowledge of manufacturing processes, use of statistical tools required, and knowledge of microbiological and chemical test methods are preferred
- Experience using statistical methods is required. Familiarity with Design Control requirements and knowledge of Medical Device Validations is preferred
Benefits
- Competitive salary and benefits package
- Flexible work arrangements, with a minimum of 4 days of in-office presence per week
- Opportunities for professional growth and development
- Recognition and rewards for performance
- Comprehensive benefits package, including medical, dental, and vision coverage
