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 relevant experience
Fda 21 cfr qsr regulatory compliance knowledge
Complaint investigation and root cause analysis skills
** Integer Group is seeking a Post Market Surveillance Engineer II to support complaint handling, regulatory reporting, and post-market surveillance processes in compliance with FDA regulations. The ideal candidate will have a background in medical devices or regulated industries, strong technical skills, and a collaborative mindset. **

Job Summary

  • The primary purpose of this role is to execute complaint handling, regulatory reporting, and post-market surveillance processes to ensure FDA compliance.
  • Candidates will perform root cause investigations, risk assessments, and support corrective and preventive actions for product quality and patient safety.
  • The company offers a comprehensive benefits package including immediate eligibility for medical, dental, vision, disability, life insurance, and a 401(k) plan with matching.

Matching Summary

Match Score: 75

** Integer Group is seeking a Post Market Surveillance Engineer II to support complaint handling, regulatory reporting, and post-market surveillance processes in compliance with FDA regulations. The ideal candidate will have a background in medical devices or regulated industries, strong technical skills, and a collaborative mindset. **

Salary

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

Skills & Requirements

Must-have

  • Bachelor's degree or 3 years relevant experience
  • FDA 21 CFR QSR regulatory compliance knowledge
  • Complaint investigation and root cause analysis skills
  • Risk assessment and CAPA support capabilities
  • Microsoft Office proficiency (Excel, PowerPoint, Visio)

Nice-to-have

  • Cross-functional collaboration abilities
  • Strong written and oral communication skills
  • Positive can-do attitude with attention to detail
  • Experience in medical device industry preferred

Key Requirements

  • Minimum Bachelor's degree required
  • At least 1 year of relevant experience
  • Knowledge of FDA regulations and QMS
  • Ability to work independently and collaboratively

Work Rights

Not specified

Tailored Resume

Cover Letter