Quality Engineer

Company: Real Staffing
Location: Oceanside
Posted on: March 16, 2023

Job Description:

Location:Oceanside, California, United States Real Staffing is looking for a Quality Engineer for one of our clients located in Oceanside, CA. The Client specializes in Dental Medical Devices.Shift: 5:30am- 3:30pm ; 4 Days a week (On-site)Location: Oceanside, CASUMMARYFocuses on manufacturing systems and process flow, software products, information systems, and process validations. The Quality Engineer will work closely with R&D, and Process Development teams, Manufacturing Operations, Quality Assurance and Regulatory to assure compliance to quality and regulatory objectives.ESSENTIAL DUTIES AND RESPONSIBILITIES - Adheres with the company's Quality Management System to ensure compliance with applicable regulatory requirements. - Equipment, Process, and Software, verification, and validation, including an understanding of test tools and methods, test documentation, test management, test traceability, defect management and tracking - Assist with Risk Management efforts - Troubleshoot and drive efficiency, cost savings and continuous process and quality improvements through application of six sigma, 5S, and lean manufacturing - Provides statistical support to analyze processes and to recommend appropriate process controls for ensuring product conformance to specification - Provide subject matter expertise for related, NCMRs, CAPAs, and complaints - Special assignments as directed by supervision commensurate with experience. - Other duties as assigned.QUALIFICATIONSThe requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. - Understanding of the FDA Quality System Regulations (21 CFR Part 820) & (ISO 13485:2016) - Understanding of IEC 62304 requirements - Working knowledge of SPC, DOE, probability, and statistics - Prior successful testing and validation of manufacturing processes in a machining environment - Know FDA and ISO requirements, how to conduct thorough validations. - Ability to demonstrate technical expertise and communicate with internal and external customers and executive management. - Must be deadline-oriented and detail-oriented, an effective communicator, and able to work within a team environment.EDUCATION and/or EXPERIENCE - Bachelor's degree from four-year College or university in Engineering, Computer Science, or equivalent experience. - 3 minimum years of experience required.CERTIFICATES, LICENSES, REGISTRATIONSASQ CQE (Certified Quality Engineer), ASQ CQA (Certified Quality Auditor) preferredEOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Keywords: Real Staffing, Oceanside , Quality Engineer, Engineering , Oceanside, California