Principal Quality Engineer
Job Description
Knowledge and Skills Set Desired
- Applied knowledge of 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)
- Knowledge/specialization in one or more of the following areas:
- Design Control - Verification, Validation, Process Validation
- Acceptance sampling theory and application
- Statistical process control methods and application
- Measurement system/test method knowledge and analysis
- 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.
- Supplier quality management
- Design/development tools
- Software validation
Quality Engineering Responsibilities
Works cross-functionally in the development and or maintenance of products or services. The Engineer is involved in resolving the equipment and process-related production issues, activities including equipment, process, materials and method validation as well as statistical analysis and metrics to analyze those systems and processes being measured.
Qualifications
Demonstrates intermediate knowledge of quality engineering policies, principles and best practices
Demonstrates intermediate knowledge of FDA/ISO requirements
Applies statistical sample size calculations to work for quality determination on projects of intermediate scope/complexity
May act as mentor to less experienced team members
Applies intermediate understanding of regulatory requirements (cGMP, FDA, ISO, etc.) to support work with little or no supervision
Writes test protocol, tests, collects data, and writes reports to validate against plan to ensure product is used as intended
Has in-depth experience, knowledge and skills in own job family
Applies knowledge and skills to a wide range of standard and non-standard situations
Works independently with minimal guidance
Usually determines own work priorities
Acts as a resource for colleagues with less experience