Post Market Surveillance Engineer Ii

The Integer Group

Base salary not specified; cash-based incentive pr...
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Bachelor's degree or 3 years experience
Fda 21 cfr qsr compliance knowledge
Complaint investigation and root cause analysis
** The Integer Group seeks a Post Market Surveillance Engineer II responsible for executing complaint handling, regulatory reporting, and post-market surveillance processes. The ideal candidate will have a background in medical devices or regulated industries and demonstrate strong organizational and communication skills. **

Job Summary

  • The primary purpose of this role is to execute complaint handling, regulatory reporting, and post-market surveillance processes in compliance with FDA 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.

Matching Summary

Match Score: 75

** The Integer Group seeks a Post Market Surveillance Engineer II responsible for executing complaint handling, regulatory reporting, and post-market surveillance processes. The ideal candidate will have a background in medical devices or regulated industries and demonstrate strong organizational and communication skills. **

Salary

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

Skills & Requirements

Must-have

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

Nice-to-have

  • Cross-functional collaboration abilities
  • Microsoft Office advanced proficiency
  • Positive can-do attitude
  • Continuous improvement mindset
  • Risk assessment for owned designs

Key Requirements

  • Minimum Bachelor's degree required
  • 1 year relevant experience (or 3 years without degree)
  • Knowledge of FDA 21 CFR QSR regulations
  • Experience with Medical Device industry preferred

Work Rights

Not specified

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