- BS in an Engineering or Life Sciences discipline.
- 3+ years Quality Engineering experience.
- Knowledge of ISO 13485:2016 and 21 CFR Part 820.
- ISO 13485:2016 Lead Auditor Certification and/or ASQ Certified Quality Engineer (CQE).
- Developing inspection procedures to ensure product conforms to specifications.
- Coordinating Receiving Inspection, Non-Conforming Material Reporting (NCMR) and Product Disposition activities.
- Assisting with complaint investigations and associated documentation.
- Interfacing with Regulatory Affairs to support FDA submissions.
- Serving as an internal auditor in support of the ShiraTronics internal audit program.
- Assisting with execution of the ShiraTronics Corrective and Preventive (CAPA) process.
- Supporting Quality Management System (QMS) ISO 13485:2016 certification activities.
- Providing Quality review of proposed documentation and/or product changes.