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 complaint handling, regulatory reporting, and post-market surveillance processes to ensure FDA 21 CFR compliance

Job Summary

  • The primary purpose of this role is to execute complaint handling, regulatory reporting, and post-market surveillance processes to ensure FDA 21 CFR compliance.
  • Candidates will perform root cause investigations, assess adverse event reportability, and support CAPA activities while collaborating with cross-functional teams.
  • The company offers a comprehensive benefits package including medical, dental, vision, 401(k) matching, and paid time off immediately upon eligibility.

Matching Summary

The primary purpose of this role is to execute complaint handling, regulatory reporting, and post-market surveillance processes to ensure FDA 21 CFR compliance.

Salary

Base salary not specified; Cash-based incentive program available; Comprehensive benefits including medical, dental, vision, life insurance, 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
  • Risk assessment for product designs
  • Strong written and oral communication
  • Ability to work independently
  • Vaccinations for product handling

Key Requirements

  • Bachelor's degree required or 3 years relevant experience
  • Minimum 1 year of relevant experience in medical device or regulated industry
  • US applicants only; Equal Opportunity Employer status

Work Rights

Not specified

Tailored Resume

Cover Letter