Post Market Surveillance Engineer Ii

Integer

Base: not specified; bonus/equity: cash-based ince...
Fda 21 cfr qsr compliance knowledge
Complaint investigation and analysis skills
Root cause analysis execution
The primary purpose of this role is to execute complaint handling, regulatory reporting, and post-market surveillance processes in compliance with FDA 21 CFR (QSR) requirements

Job Summary

  • The primary purpose of this role is to execute complaint handling, regulatory reporting, and post-market surveillance processes in compliance with FDA 21 CFR (QSR) requirements.
  • Candidates must possess a bachelor's degree or at least three years of relevant experience in the medical device or regulated industry.
  • The company offers a comprehensive benefits package including medical, dental, vision, life insurance, and immediate 401(k) matching contributions.

Matching Summary

The primary purpose of this role is to execute complaint handling, regulatory reporting, and post-market surveillance processes in compliance with FDA 21 CFR (QSR) requirements.

Salary

Base: Not specified; Bonus/Equity: Cash-based incentive program available; Benefits: Comprehensive medical, dental, vision, life, disability, and 401(k) match

Skills & Requirements

Must-have

  • FDA 21 CFR QSR compliance knowledge
  • Complaint investigation and analysis skills
  • Root cause analysis execution
  • CAPA assessment and support experience
  • Adverse event reportability assessment

Nice-to-have

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

Key Requirements

  • Bachelor's degree required
  • Minimum 1 year relevant experience
  • Medical device or regulated industry experience preferred

Work Rights

Not specified

Tailored Resume

Cover Letter