Quality Systems Manager Lead

2 days ago


Mansfield, Massachusetts, United States Integra LifeSciences Full time
Key Responsibilities

The Senior Quality Systems Engineer is responsible for supporting the site Quality Management System (QMS), driving improvements to the QMS, having oversight of and ensuring compliance to the Complaint, CAPA, Audit, and Quality Planning processes, acting as the Internal Audit Manager, and providing experienced quality assurance support to manufacturing and product development teams as well as lower-level Quality Engineers. The estimated salary for this role is $90,000 - $120,000 per year.

Requirements
  • Bachelor's degree in a scientific discipline required with minimum 5 years' experience in the medical device or pharmaceutical industry.
  • Strong knowledge of FDA Quality Systems Regulations, GMP, ISO 13485 and other global regulations and standards.
  • Strong analytical skills, exceptional writing and interpersonal relationship skills or combination of relevant work experience and education.


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