Post Market Surveillance Engineer Ii

The Integer Group

Base salary not specified; cash-based incentive pr...
Not specified
Bachelor's degree or 3 years experience
Fda 21 cfr qsr compliance knowledge
Complaint investigation and root cause analysis
The Integer Group is seeking a Post Market Surveillance Engineer II to support complaint handling, regulatory reporting, and post-market surveillance processes. The ideal candidate will have a bachelor's degree and relevant experience in a regulated industry, demonstrating strong technical and organizational skills

Job Summary

  • The primary purpose of this role is to execute and support complaint handling, regulatory reporting, and post-market surveillance processes for Integer.
  • Candidates must demonstrate the ability to work independently while collaborating with cross-functional teams to investigate product complaints and ensure patient safety.
  • The company offers a comprehensive benefits package including medical, dental, vision, disability, life insurance, and immediate 401(k) matching.

Matching Summary

Match Score: 75

The Integer Group is seeking a Post Market Surveillance Engineer II to support complaint handling, regulatory reporting, and post-market surveillance processes. The ideal candidate will have a bachelor's degree and relevant experience in a regulated industry, demonstrating strong technical and organizational skills.

Salary

Base salary not specified; Cash-based incentive program available; Comprehensive benefits including medical, dental, vision, 401(k) match, and 80 hours holidays

Skills & Requirements

Must-have

  • Bachelor's degree or 3 years experience
  • FDA 21 CFR QSR compliance knowledge
  • Complaint investigation and root cause analysis
  • Risk assessment and CAPA support
  • Adverse event reportability assessment

Nice-to-have

  • Cross-functional collaboration skills
  • Microsoft Office advanced proficiency
  • Positive can-do attitude
  • Continuous improvement mindset
  • Strong written and oral communication

Key Requirements

  • Minimum Bachelor's degree required
  • At least 1 year relevant experience (or 3 years without degree)
  • Knowledge of FDA regulations and international requirements
  • Experience in medical device or regulated industry preferred

Work Rights

Not specified

Tailored Resume

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