Senior Quality Engineer
BD
- Bangalore, Karnataka
- Permanent
- Full-time
- Applied knowledge of the FDA medical device quality system regulations and international quality system standards/regulations (e.g. - 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, EU MDR/IVDR) as it relates to the design and continued support of BD products.
- Applied knowledge of Corporate and/or Unit requirement.
- Able to contribute to the completion of specific programs and projects.
- Can ensure quality conduct of projects, including design, data summary and interpretation, and report generation for self and lower level project developers.
- Able to revise policies and procedures
- Able to make presentations
- Can independently determine and develop approach to solutions.
- Able to provide guidance and work direction to lower level project developers.
- Can design and perform development working independently within defined parameters with minimal supervision required.
- Experience with BD software systems utilized in the Quality Systems is desirable.
- Must have knowledge/specialization in one or more of the following areas:
- Acceptance sampling theory and application
- Statistical process control methods and application
- Measurement system/test method knowledge and analysis
- Quality planning
- Failure analysis investigation
- Design of Experiments
- Process mapping and value stream analysis
- Hypothesis testing
- Descriptive statistics
- Process capability analysis
- Basic quality tools: Pareto, box plots, histograms, scatter diagrams, etc.
- Risk Management
- Supplier quality management
- Auditing
- Design/development tools
- Process validation
- Software validation