Post Market Surveillance Engineer Ii

The Integer Group

Base salary not specified; cash-based incentive pr...
Not specified (potentially hybrid or on-site based on job responsibilities).
Fda 21 cfr qsr compliance
Complaint investigation execution
Root cause analysis skills
The Integer Group is seeking a Post Market Surveillance Engineer II to support complaint handling, regulatory reporting, and post-market surveillance processes. The role emphasizes collaboration, adherence to FDA regulations, and quality management while contributing to product safety and customer satisfaction

Job Summary

  • The primary purpose of this role is to execute and support Complaint Handling, Regulatory Reporting, and Post Market Surveillance processes in compliance with FDA regulations.
  • Candidates must possess a bachelor's degree or equivalent experience along with the ability to work independently on product investigations and risk assessments.
  • The company offers a comprehensive benefits package including medical, dental, vision, life insurance, and immediate 401(k) matching contributions.

Matching Summary

Match Score: 80

The Integer Group is seeking a Post Market Surveillance Engineer II to support complaint handling, regulatory reporting, and post-market surveillance processes. The role emphasizes collaboration, adherence to FDA regulations, and quality management while contributing to product safety and customer satisfaction.

Salary

Base salary not specified; Cash-based incentive program available; Comprehensive benefits package including 401(k) match

Skills & Requirements

Must-have

  • FDA 21 CFR QSR compliance
  • Complaint investigation execution
  • Root cause analysis skills
  • Risk assessment capabilities
  • CAPA investigation support

Nice-to-have

  • Cross-functional collaboration
  • Continuous improvement mindset
  • Microsoft Office proficiency
  • Positive can-do attitude
  • Audit support experience

Key Requirements

  • Bachelor's degree required
  • Minimum 1 year relevant experience
  • Knowledge of FDA 21 CFR QSR
  • Experience in medical device industry preferred

Work Rights

Not specified

Tailored Resume

Cover Letter