Supplier Quality Assurance Engineer
Purpose of the Position:
The Supplier Quality Assurance Engineer is responsible for supporting the Supplier Quality Program and providing cross-functional support to Product Development and Operations throughout the product life cycle in order to ensure the highest quality materials and products from suppliers that meet requirements while improving the Cost of Quality of parts, processes and products. This includes collaborating with contract manufacturers and various internal departments to ensure continuous improvement and implementation of identified projects/systems. This position is also responsible for maintenance and continuous improvement of the DxTerity Diagnostics Quality System in compliance with the requirements of the FDA Quality System Regulations (21 CFR 820), ISO 13485, and DxTerity Quality Manual.
- Responsible for maintaining the supplier quality management program.
- Day to day activities include; supplier auditing, SCAR management, Supplier NCR investigations, Supplier file maintenance, Supplier metrics, ASL
- Resolve issues at the supplier impacting product quality.
- Support in house operations and customer complaint issues related to supplier parts.
- Assist receiving inspection as needed.
- Participate in the supplier qualification, approval and selection process.
- Team member on supplier related projects.
- Support Quality Assurance and Regulatory Affairs, as needed.
- Other duties, as assigned.
- Up to 30% travel required.
Education and Experience:
- BS in Engineering/Science or related field
- Minimum 5 years industry experience, preferably in an FDA regulated environment
- Experience in In Vitro Diagnostics, Nucleic Acid-based Chemistry, Molecular Genetics, Gene Expression Platform Analysis, and/or NGS Technologies are a plus.
- Able to work in a fast-paced, start-up company environment.
- Flexible self-starter, able to work independently with little supervision.
- Demonstrated understanding of auditing principles.
- High level of competence in Quality including formal root cause analysis and managing deployment of corrective and preventive actions.
- Strong communication, detail, and organization skills required.
- Good judgment skills within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
- ASQ CQE or CQA preferred.