Basic Purpose of Position: Assist in the development and implementation of Quality Procedures in compliance with the ISO-13485.
1. Primary or Major Responsibilities: - Failure mode and root cause analysis of incoming and field failures
- Production process review and auditing
- Assist in internal and supplier audits
- Create quality plans
- Maintain regulatory compliance
- Maintain Device History Files
- Support the development, maintenance, and auditing of the Quality Management system.
- Assist in development and implementation of applicable processes to meet Customer requirements, including training, problem solving, and review meetings.
- Manage trace matrix for medical device design control
- Lead project risk management activities
- Work directly with customers to develop product level and system level design specifications
- Support FDA submission with project documentation
- Compile CE technical files
- Drive continuous improvement across facility Key Process Indicators.
- Aid in reliability testing.
2. Safety: - Ensure that all assignments are performed in compliance with all applicable Federal, State, Provincial and Company safety and health regulations, and where applicable, proper personal protective equipment is utilized.
3. Minimum Requirements: - Bachelor's degree in Engineering field or area of study deemed acceptable by the hiring team
- Minimum of 3 to 5 years engineering experience in related manufacturing position
- Experience developing medical product requirements and specifications
- Experience developing and executing verification protocols for medical devices
- Thorough understanding of FDA medical device regulations and design control processes
- Thorough understanding of ID regulatory requirements
- Thorough understanding of IEC 60601 3rd edition
- Ability to function effectively in a team environment.
- Effective communication skills driven by attention to detail
- Strong DFM and NPI skills.
- Excellent analytical skills using Six Sigma and Lean Principles
- Good working knowledge of quality/reliability engineering statistical techniques
- Self motivated and self managed
- Ability to handle multiple projects at the same time