QMS Program Manager

Quality Systems Program Manager (Through end of January 2025 // REMOTE, team based in Northridge, CA):Position is expected to extend an additional 12+ months

HM's Top Needs:Medical Device industry experience (15+ years)QMS, Inspection Readiness activitiesProject Management (5-10+ years)

Years’ Experience Required: +15

Duties:Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.Leads inspection readiness program, coordinates resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.Prepares reports and/or necessary documentation (ex. Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.Required/Preferred Skills:Experience project manager in the medical device industry, responsible for the inspection readiness program and QMS related projects related to Diabetes products.Strong knowledge and experience dealing with regulatory requirements and standards including 21CFR820 and ISO 13485:2016.Expected Bachelor’s Degree, preferable in engineering. Master’s degree preferred.Requires at least 15 years of experience in medical device industry, which needs to include 5-10 years of project and program management roles.

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