Integrated Resources, Inc ( IRI ) | Quality Systems ...

Title: Quality Systems SpecialistLocation: Rocklin, CADuration: 12 months+M-F 8am-5pmBachelor's DegreeAt least 2 years of experienceRisk managementassessment (medical device), validation and data controlintegrity experiencePlus: SAP and TrackwiseThe Quality Systems Specialist support site QMS and ensure compliance of the quality system (QS) with regulations relevant to the business, including but not limited to following standardsregulations ISO 13485, IVDR (EU), IVDD (EU), 21 CFR part 20 and part 11, ISO 14971 and GxP. Individual represents Quality on cross-functional teams to support business needs and may lead quality initiatives driving positive site Quality culture. Prepares QS documentation and reports as needed for routing operations support, site metrics and management review.

Created: 2025-01-14