This position is responsible for assisting engineers in developing and maintaining quality engineering methodologies and providing quality technical support within new product development, manufacturing, or system/services support.
- Assist in designing, building, and evaluation of test methods and inspection fixturing
- Coordinate and perform inspection and testing of developmental product
- Assist in writing, executing and documenting equipment, product, process, and test method verifications, qualifications, and validations and initiate related documentation changes.
- Perform final product inspections against specification and procedural requirements.
- Perform first article and incoming inspection of purchased components and inspection of production operations, including documenting inspection and test results.
- Monitor and/or perform calibration and maintenance of all test equipment and fixtures
- Document nonconformances as appropriate and assist in the resolution of nonconformances
- Collect data, summarize, analyze, perform basic statistical analysis on, and document test results
- 2 year technical degree or equivalent course work
- Minimum of 5 years’ experience in medical device or related field
- Previous experience in assisting with verification and validation testing, test methods, inspections, and nonconforming material dispositioning
- Knowledge of standards, FDA, and ISO 13485
- Experience with metrology and measurement systems
Preferred Qualifications: (Optional)
- Training in blueprint reading
- Good communication and computer skills, including data analysis and report writing skills
- ASQ CQT certification or equivalent
- Experience with catheter based products
- Experience with data analysis and statistical based approaches
Indeed - 17 months ago