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Quality Systems Manager/Compliance
2 months ago
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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