Post Market Surveillance Engineer Ii

The Integer Group

Base salary not specified; cash-based incentive pr...
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Fda 21 cfr qsr compliance knowledge
Complaint investigation and analysis skills
Root cause investigation execution
** The Integer Group is seeking a Post Market Surveillance Engineer II responsible for executing complaint handling, regulatory reporting, and post-market surveillance processes to ensure compliance with FDA and other regulatory requirements. The ideal candidate should possess a bachelor's degree and relevant experience, demonstrating strong technical aptitude, independence, and collaboration 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 21 CFR requirements.
  • Candidates will be responsible for performing root cause investigations, risk assessments, and supporting CAPA investigations to ensure product quality and patient safety.
  • The company offers a comprehensive benefits package including medical, dental, vision, life insurance, and immediate eligibility for a 401(k) plan with company matching.

Matching Summary

Match Score: 75

** The Integer Group is seeking a Post Market Surveillance Engineer II responsible for executing complaint handling, regulatory reporting, and post-market surveillance processes to ensure compliance with FDA and other regulatory requirements. The ideal candidate should possess a bachelor's degree and relevant experience, demonstrating strong technical aptitude, independence, and collaboration skills. **

Salary

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

Skills & Requirements

Must-have

  • FDA 21 CFR QSR compliance knowledge
  • Complaint investigation and analysis skills
  • Root cause investigation execution
  • CAPA assessment and support experience
  • Adverse event reportability assessment
  • Microsoft Office proficiency (Excel, PowerPoint)

Nice-to-have

  • Cross-functional collaboration abilities
  • Strong written and oral communication
  • Positive can-do attitude
  • Experience with quality management systems
  • Ability to work independently

Key Requirements

  • Bachelor's degree required or 3 years relevant experience
  • Minimum 1 year of relevant experience in medical device industry
  • Knowledge of US and International regulatory requirements

Work Rights

Not specified

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