Post Market Surveillance Engineer Ii

Integer

Base salary not specified; cash-based incentive pr...
Fda 21 cfr qsr compliance knowledge
Complaint investigation and analysis
Root cause investigation execution
The primary purpose of this role is to execute and support Complaint Handling, Regulatory Reporting, and Post Market Surveillance processes to ensure FDA compliance

Job Summary

  • The primary purpose of this role is to execute and support Complaint Handling, Regulatory Reporting, and Post Market Surveillance processes to ensure FDA compliance.
  • Candidates will be responsible for performing root cause investigations, risk assessments, and CAPA activities while collaborating with cross-functional teams to ensure patient safety.
  • 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 and support Complaint Handling, Regulatory Reporting, and Post Market Surveillance processes to ensure FDA compliance.

Salary

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

Skills & Requirements

Must-have

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

Nice-to-have

  • Positive can-do attitude
  • Continuous improvement ideation
  • 5 Sigma quality journey experience
  • Strong written and oral communication
  • 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

Tailored Resume

Cover Letter