Manager Quality Operations

Insulet Corporation

Not specified
Us fda regulatory compliance
Iso 13485 quality management systems
Mdsap mdr regulatory requirements
Insulet Corporation is seeking a Manager of Quality Operations to ensure compliance with regulatory standards in the medical device industry. The role focuses on quality control testing, documentation review, and product release while promoting a culture of quality and compliance within the organization

Job Summary

  • The role ensures full compliance of the site quality system with US FDA, ISO 13485, MDSAP/MDR, and other applicable country-specific regulatory requirements.
  • The manager is responsible for establishing a strategy for compliance with quality objectives and ensuring timely evaluations and investigations to maintain product safety and efficacy.
  • Insulet Corporation is an innovative medical device company dedicated to simplifying life for people with diabetes through its Omnipod product platform.

Matching Summary

Match Score: 85

Insulet Corporation is seeking a Manager of Quality Operations to ensure compliance with regulatory standards in the medical device industry. The role focuses on quality control testing, documentation review, and product release while promoting a culture of quality and compliance within the organization.

Skills & Requirements

Must-have

  • US FDA regulatory compliance
  • ISO 13485 quality management systems
  • MDSAP MDR regulatory requirements
  • QC testing and product release
  • Device Master Record requirements
  • Internal and external QMS audits

Nice-to-have

  • Process improvement opportunities
  • Cross-function team leadership
  • Culture of compliance focus
  • Employee training process management
  • Efficiency enhancement strategies

Key Requirements

  • Bachelor's degree in science or engineering
  • 7+ years experience in Medical Device Quality Operations
  • Extensive knowledge of manufacturing and engineering techniques
  • Experience designing QMS processes for ISO 13485 and 21 CFR 820

Work Rights

Not specified

Tailored Resume

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