Quality Inspector (Temp) - 21648

Quality Inspector (Temp) - TalentZokOVERVIEW Are you looking for a new career opportunity with an exciting company?! Then we've got the right team for you! In this role, you're responsible for the duties listed below. Immediate opening for a Quality Inspector (Temp) in Aliso Viejo, CA who possesses:Basic understanding of the quality inspection processExperience inspecting parts under a microscopePrior experience working in a cleanroom is preferred Email resumes to mrico@talentzok.com or call 949.204.3861. FULL DESCRIPTION: Performs quality functions to support ISO 13485, FDA, CGMP, Quality System Regulations, management reporting, product/QA/QC, chemistry QA/QC, product release, in- process inspection, incoming inspection, quality process improvements for company products, manufacturing transfer, and facility support. The selected candidate will be responsible for:Perform optical and mechanical inspections with optical comparator, LPS, OCT, Nanovea, interferometer, Spectro radiometer, radiometer, calipers, micrometers, visual inspection systems, microscope, Keyence, Confocal microscope, Smartscope, etc.Read, comprehend, and follow documents related to manufacturing, inspection and quality systems for audits, compliance, and implementation.Perform batch records review, in-process verification, and quality checks for product as required.Audit and approve production records.Verify production process via auditing/observation and testing.Inspect process output and product parameters against specifications.Ensure routine compliance with process steps and proper documentation of records.Maintain raw material lot information, monitor expiration date and quarantine inventory when materials are expired.Performs incoming inspection on raw materials and incoming sub- assemblies/finished goods.Collect data for process, quality system, manufacturing quality and performance metrics and generate reports for management review.Revises, writes, and formats Quality System controlled documentation, including procedures, forms and engineering documents, incoming inspection, and product.Initiates, implements and controls Change Notifications and Engineering Change Orders, incoming inspection and as required.Identify non-conformances, deviations, non-compliance, lack of calibration etc. and propose corrective actions to management.Facilitate Manufacturing Review Board and supports non- conformance decision process.Govern and transact materials physically and through electronic system.Monitors laboratory and engineering equipment to ensure compliance with preventive maintenance and calibration programs.Performs laboratory notebook audits, inventory audits, and maintains QA retains.Take initiatives for the process improvements changes as related to manufactured components and finished productsResponsible for assisting the Quality Assurance team with any ad hoc reports and assignments as required.Perform incoming inspection and lot control activities of materials and parts.Assist Quality, Manufacturing and R&D groups in running validation, verification, and developmental studies, and defining processes.Development of inspection techniques and transfer to production and everyday use.Monitor gowning and cleanroom logbook check per SOP to ensure all sections of the cleaning log has been filled accurately and completely.Provide Good Manufacturing Practices (GMP) and Quality Standard Operating Procedures (SOP) training to relevant department.Create and review First Article Inspection Reports when necessary.  The selected candidate will also possess:Prior experience/ knowledge in optical and mechanical inspection techniquesExperience in inspecting minute parts under microscope.Basic understanding of inspection processesPrior experience of working in cleanroom environment and/ or medical device manufacturing is highly preferred.Professional, responsible, energetic and accountable.Excellent communication skills.Intellectually curious and eager to learn.Individual must be Quality oriented and possess a natural ability to pay attention to detailsAssociate degree (A.A.) or equivalent from a two-year college or technical school; six months to one-year related experience and/or training; or equivalent combination of education and experience.Experience within a medical device company or regulated industry preferred.Microsoft Word; Microsoft ExcelTraining to be completed per the training plan for this position as maintained in the document control systemThe training requirements on TRN-10007 Insider Trading Policy, TRN-10008 Global Anti-Bribery and Anti-Corruption Policy and TRN-10009 Code of Business Conducts and Ethics must be diligently completed within 30 days from the hiring date and on an annual basis   Salary Range: $22-$24/hrFor immediate and confidential consideration, please email your resume to mrico@talentzok.com or call 949.204.3861. More information can be found at www.talentzok.com Company DescriptionTalentZok was founded in 2008 and has been repeatedly recognized as one of San Diego County's fastest growing businesses. In 2022, we were named Business Journal's 'Best Places to Work'. Even as our competitors are scaling back and laying off staff, TalentZok is expanding to new markets and hiring additional staff in existing offices.

Salary : $22 - $24