Principal Responsibilities
- Perform Test Method Validations for all in-process monitoring, analytical laboratory tests, and final release inspection and testing
- Participate in internal and external quality audits
- Practical application of Corrective Actions and Preventive Actions (CAPA) system
- Develop, execute, and analyze quality-reporting measures
- Report to management on quality issues, trends, and losses
- Monitor storage and distribution of components and finished goods
- Serve as a resource to internal departments for problem identification and resolution
- Support concurrent engineering efforts by representing Quality in design development projects
- Design and implement methods for process control, process improvement, testing, and inspection
- Conduct trend analysis of non-conformances and other quality indicators as needed
- Participate in supplier selection, assessment, and monitoring program
- Participate in quality control activities such as batch records, receiving records, environmental monitoring, and product release
Required Education and Experience
- B.S. degree in a scientific discipline (Chemistry, Biology, Physics, Biomedical Engineering, Chemical Engineering, etc.)
- Minimum of 3 – 5 years of Quality engineering experience in the biomedical industry, preferably in medical devices
- Thorough understanding and application of validation principles with an emphasis on Test Method validation
- CQE, CQA, Six Sigma Black/Green belt preferred
- Well-versed in CFR Part 820, Part 11, ISO 13485, and ISO 14971 Standards
- Quality engineering experience with analytical tools
- Experience in applying statistical methods for quality improvements
- Experience in design control and process validation, root cause analysis, and corrective and preventive action (CAPA)
Required Knowledge, Skills, and Abilities
- Computer literacy—experience with Microsoft Outlook, Excel, PowerPoint, Word, Access, and project databases
- Management and/or interaction with multilevel staff
- Excellent organizational skills; organized file management
- Strong communication skills, both written and verbal
- Professional, assertive demeanor
- Knowledge in supplier quality engineering and management
