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