Job Details:
Quality Assurance Engineer – Medical Device
Job Duties:
- Sort through and analyze data to maintain and ensure quality standards are met
- Oversee quality technicians to ensure parts measure up to standards
- Work with measurement tools
- Ensure that both materials and completed projects are in compliance with quality regulations
- Conduct validation activities
- Ensure new and existing equipment is up to quality standards
- Keep clean records and help maintain an accurate database
- Be able to answer questions and help other team members with quality regulations
- Create and execute audit schedules
- Experience with CAPA systems
- Maintain ISO standards
- Interact with the purchasing department to suppliers and materials purchased are up to quality standards
- Keep records of suppliers and evaluate to make sure they are the right suppliers for our operations
- Help establish or change existing quality procedures and manufacturing practices
Requirements:
- Bachelor’s Degree in Engineering or related scientific field
- 4 or more years of experience in medical device manufacturing
- Experience working with quality measurement tools such as gauges, cmm's, etc.
- Validation experience
- Experience with ISO systems used in a medical device setting
- FDA Experience
- CAPA experience
- Experience working with purchasing and suppliers
- Excellent communicate and organizational skills