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Quality Assurance Associate

Company: Inari Medical
Location: Irvine
Posted on: January 27, 2023

Job Description:

Description The Quality Assurance Associate supports efficient operation of the Quality Assurance department and compliance to FDA GMP, ISO 13485, MDSAP and other applicable regulatory requirements.ResponsibilitiesReviews in-process subassembly and finished product manufacturing routers (including engineering/R&D builds) for accuracy and completeness.Reviews training records for manufacturing personnel.Compiles device history record and releases lots into inventory.Submits samples for pyrogen and bioburden testing to test labs.Organizes Quality files and scanning activities.Works with other members of the QA team to achieve departmental/company goals.Identifies and implements any changes necessary to the quality systems and compliance procedures to ensure and maintain the continued suitability and effectiveness of the quality management system.May support audit activities including supporting external audits and addressing audit findings.Performs other duties as assigned, according to the changing needs of the business.QualificationsHigh school diploma or equivalent.Previous minimum 4 years QA/QC experience. Preferred experience with medical device manufacturer.Computer skills including Word, Excel and Internet Experience.General knowledge of 21 CFR 820, ISO 13485 and other applicable regulatory standards.Detail oriented and organized.Able to work independently with minimal supervision.Able to prioritize and efficiently complete tasks with consistency and accuracy.Inari Medical offers competitive health and wealth benefits for our employees. The base pay for this position is $26.00 an hour. A range of factors, including background and experience, will be considered. Actual compensation may vary. For United States Applicants Only: Inari Medical E-Verify Poster (English and Spanish) Inari Medical Right to Work Poster (English) Inari Medical Right to Work Poster (Spanish)

Keywords: Inari Medical, Irvine , Quality Assurance Associate, Other , Irvine, California

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