Quality Assurance Manager

6 days ago


Mansfield, Massachusetts, United States Integra LifeSciences Full time

**About Us**

At Integra LifeSciences, we're dedicated to transforming lives and building careers. Our team is passionate about creating change and shaping the future of healthcare.

We're seeking a skilled Senior Quality Systems Engineer to join our team. This exciting opportunity allows you to drive improvements in our Quality Management System (QMS) and ensure compliance with regulations and internal procedures.

The estimated salary for this position is $120,000 - $180,000 per year, depending on your location and experience.

About the Role

The Senior Quality Systems Engineer will be responsible for:

  • Driving improvements to the QMS
  • Ensuring compliance to the Complaint, CAPA, Audit, and Quality Planning processes
  • Acting as the Internal Audit Manager
  • Providing quality assurance support to manufacturing and product development teams

This role requires a strong understanding of FDA Quality Systems Regulations, GMP, ISO 13485, and other global regulations and standards. Previous experience documenting, reviewing, and approving CAPAs is also required.

Key Responsibilities

  • Maintaining the Quality Manual and site Quality System related procedures
  • Analyzing current and future procedural needs of the business
  • Organizing and managing the plant internal audit system
  • Conducting Quality System Audits and assisting in training/guidance to other internal auditors

Requirements

  • Bachelor's degree in a scientific discipline
  • Minimum 5 years' experience in the medical device or pharmaceutical industry
  • Strong knowledge of quality systems and regulations
  • Excellent communication and leadership skills


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