Quality Engineer II
On-siteSan Clemente, California, United States
Job Summary
Conduct product nonconformity investigations, initiate Corrective and Preventative Actions (CAPA), and lead complaint evaluations for Class III medical devices. Develop trend requirements for NCR, CAPA, and SPC processes to support incoming inspection, manufacturing, and vendor operations. Write, review, and approve validation protocols, equipment qualifications, and document change orders while performing statistical analysis to improve processes. Manage equipment and facility requirements, including clean room design, maintenance, and calibration programs. Ensure compliance with Federal, State, local regulations, GMP, and ISO 13845 standards. Assist in defining internal and external product validations and maintain risk analyses for all development products.
Required Qualifications
- Bachelor's degree in Engineering or Science", "2-5 years of relevant work experience", "Strong knowledge of medical device manufacturing", "Expertise in medical product quality assurance (including the requirements for test protocols and statistical techniques)", "Working understanding of GMP and ISO 13845 requirements", "A work style of hands-on involvement with all phases of projects", "Excellent documentation skills with attention to detail and accuracy Required", "Team player", "good writ...
Desired Qualifications
- Experience working in a clean room and/or performing in-process assembly and manufacturing verification inspections desirable
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