01 Apr
Quality Engineer III
Vacancy expired!
job summary:The Quality Engineer is responsible for supporting Design validations and verification through adherence to design control and good documentation practice requirements. Regulatory experience is required in the position. This role also works hand in hand with R&D and Risk and will require someone to be collaborative and efficient. location: SAN CLEMENTE, Californiajob type: Contractsalary: $45 - 50 per hourwork hours: 8am to 4pmeducation: Bachelors responsibilities:
- Initiate and manage main documents of Design Input, Design Output, Design V&V and Design changes.
- Work with R&D in collecting and managing data of Remediation projects and on creating Design V&V protocols and reports.
- Work with R&D Manage and initiate accelerated aging protocols/reports & support sterility studies.
- Create and edit design documents supporting technical assessment, testing reports and regulatory submissions.
- Manage Risk & lead Risk Assessment (HA, DFMEA, PFMEA, etc.).
- Work with R&D, Quality Engineers and Manufacturing Engineers on qualification of new and modified Design.
- Ensure the readiness of internal and/or external audits including the support as Audit Prescriber.
- Manage continuous improvement projects.
- Experience level: Experienced
- Minimum 6 years of experience
- Education: Bachelors (required)
- Quality Engineer (4 years of experience is required)
- Design Engineer
- Regulatory Compliance
- Risk Management
Vacancy expired!