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Quality Systems Manager

2 months ago

Mansfield, United States Oxenham Group Full time

Position: Quality Systems Manager

Location: Onsite in Mansfield, MA

Responsibilities

Oversee compliance and the quality system including doc control, complaints, CAPA, NCMR, internal audit etc. Establish and manage Quality Compliance Budget Drives the development and improvement of new processes, implementation of standards, and Quality Plans in support of the organization's Quality strategies. Manage Doc Control and Quality Records processes and personnel Lead external regulatory body audits and inspections Manage Quality Management Review

Qualifications

Bachelor's degree in STEM 5-7 years of experience as a manager in the Medical Device Industry. Strong knowledge of FDA regulations Experience in the front room of Audits

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