Description
4. Purpose of Position:The position of a Senior Engineer is to provide engineering and technical support for the company's products and processes. Develop and execute method and process validations. Assess the impact of design and process changes on existing products and processes. Participate in the review of risk analysis and develop new risk assessments as required. Support Complaint, NCMR and CAPA investigations. Recommend and implement improvements to the Quality System as required. The incumbent may also participate in Internal, External and Supplier audits.
5. Essential Functions:
- Support device manufacturing through development of inspection procedures, tools and fixtures, process development and validation.
- Develop and validate test methods in CER, Lot Release Testing and Design Verification
- Develop and execute Gauge R & R studies
- Oversee implementation of Master Validation Plan.
- Develop, write and execute validation test protocols
- Develop process FMEA and support changes in existing risk analyses
- Support complaint investigations
- Oversee CER Environmental Monitoring program.
- Participate in NCMR investigations and Calibration/ PM out of tolerance investigations.
- Manage CAPA investigations.
- Develop and oversee Packaging, Distribution and Sterilization Validations
- Biocompatibility testing and assessments.
- Generate internal quality documentation such as quality plans, standard operating procedures and inspection procedures
To find out more about Real please visit www.realstaffing.com