Supports the development and manufacture of medical devices. Will work with Manufacturing and R&D to resolve product quality issues.
Supports manufacturing process changes, product design improvements and the implementation of new products.
Works with manufacturing engineers to review process changes and resolve product quality issues.
Works with suppliers to maintain high quality levels of incoming production materials.
Conducts quality audits of suppliers.
Work with R&D engineers to support implementation of new products by reviewing quality and testing plans.
Works with R&D and manufacturing engineers to develop the DFMEA and PFMEA.
Works with R&D and manufacturing engineers to develop test protocols and reports (design verification, design validation, process qualification and process validation)
As assigned, maintains various Quality Systems such as CAPA, Non-Conformance (NCR), supplier quality, equipment calibration, internal auditing and quality metrics data analysis.
Degree in related field or equivalent.
Minimum of 3 - 5 years of related experience. Good communication skills. Knowledge of medical product manufacturing