Sr. Quality Engineer - Diverse Linx
Irvine, CA
About the Job
| Job Title | Sr. Quality Engineer |
| Relevant Experience (in Yrs) | A minimum with 5+ years of related experience Quality Management in Medical Device Industry |
| Technical/Functional Skills | Knowledge of Medical procedure and corresponding Medical Equipment Knowledge of Medical Equipment manufacturing processes Knowledge on Quality Management and its tools & techniques Knowledge about FDA, ISO 13485, ISO 14971 and compliance regulations Knowledge on Medical Device Regulatory Standards, MDD and MDR Knowledge on NC, CAPA, Audit processes Knowledge in Statistic, Risk Management and Design control Must possess good communication skills (verbal and written), familiar with project management methodology, problem solving, and presentation skills |
| Experience Required | 5+ Years |
| Roles & Responsibilities | Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Pharmaceutical, procedures and guidelines, the duties and responsibilities for this position are: Working with other functional groups, including R&D and Operations in support of new product development, engineering projects, quality assurance activities, and lifecycle management. Utilizing Quality Engineering tools/processes in development and implementation of practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle. Oversight, from a Quality NPD perspective, of the Non-Conformance Report (Client) process for BWI facilities located in the U.S. Develop and establish effective quality control and support associated risk management plans, AFMEA, DFMEA and PFMEA. Write, review and/or approve process and product validation protocols and reports, equipment qualifications, engineering change |
Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.
Source : Diverse Linx