Senior Quality Engineer responsible for setting guidelines on inspection and testing requirements, ensuring product compliance, and leading CAPA and process improvement initiatives.
Requirements
- Bachelor’s degree in engineering field or related field
- 3-7 years of experience in high volume regulated manufacturing industry in engineering field
- Six Sigma, lean, and Quality Management Tools
- Access Database, Excel, and complaint handling software
- ISO13485, ISO14971, CFR part 820
- Medical device regulation, industry, and international standards
- Strong computer skills in MS Office
- Ability to recognize and projects
- Ability to read and understand technical drawings and documents
- CAD/SolidWorks
- Excellent communication, analytical, trouble-shooting, and interpersonal skills