Quality Systems Manager/Compliance

2 months ago


Mansfield, United States CareerBuilder 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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