Post Market Surveillance Engineer Ii

The Integer Group

Base salary + cash-based incentive program; compre...
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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 is seeking a Post Market Surveillance Engineer II to manage complaint handling and regulatory reporting processes in compliance with FDA requirements. The ideal candidate will have a background in the medical device industry, demonstrating strong analytical skills and a collaborative approach to problem-solving. **

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 adhere to FDA 21 CFR (QSR) requirements and other regulatory bodies while performing complaint investigations and risk assessments.
  • 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 is seeking a Post Market Surveillance Engineer II to manage complaint handling and regulatory reporting processes in compliance with FDA requirements. The ideal candidate will have a background in the medical device industry, demonstrating strong analytical skills and a collaborative approach to problem-solving. **

Salary

Base salary and cash-based incentive program; Comprehensive benefits package including medical, dental, vision, disability, life insurance; 401(k) with company matching

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 risk assessment skills
  • Microsoft Office proficiency (Excel, PowerPoint)

Nice-to-have

  • Cross-functional collaboration abilities
  • Strong written and oral communication
  • Positive can-do attitude
  • Experience in medical device industry
  • Ability to work independently

Key Requirements

  • Minimum Bachelor's degree required
  • At least 1 year relevant experience preferred
  • Knowledge of US and International regulations

Work Rights

Not specified

Tailored Resume

Cover Letter