Client: Medical Device
Project Details:
- 6-Month contract, with the potential of FTE conversion.
- 40 hours of work per week.
- On-site in Irvine.
Responsibilities
- Lead sustaining engineering activities for Class II medical devices, including process controls, validations, and in-process inspection strategies to ensure ongoing product quality.
- Drive CAPA, NCMR, and failure investigations; coordinate cross-functional teams to assess and implement component, product, and process changes.
- Support equipment qualification, process validation, test method validation, and ISO 14971 risk management activities in partnership with Operations and Supplier Quality.
Qualifications
- BS in Engineering or related field.
- Strong knowledge of ISO 13485, ISO 14971, and 21 CFR 820, including design, purchasing, risk, and process controls.
- Proven experience leading CAPA investigations and supplier corrective actions.
- ASQ CQE preferred.
Featured benefits
Medical insurance, Vision insurance, Dental insurance, 401(k)