Post Market Surveillance Engineer Ii

Integer

Base salary not specified; cash-based incentive pr...
Bachelor's degree or 3 years experience
Fda 21 cfr qsr compliance knowledge
Root cause investigation skills
The primary purpose of this role is to execute and support Complaint Handling, Regulatory Reporting, and Post Market Surveillance processes for Integer

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 immediate eligibility for medical, dental, vision, disability, life insurance, and a 401(k) plan with matching.

Matching Summary

The primary purpose of this role is to execute and support Complaint Handling, Regulatory Reporting, and Post Market Surveillance processes for Integer.

Salary

Base salary not specified; Cash-based incentive program available; Comprehensive benefits package included

Skills & Requirements

Must-have

  • Bachelor's degree or 3 years experience
  • FDA 21 CFR QSR compliance knowledge
  • Root cause investigation skills
  • CAPA assessment and execution
  • Adverse event reportability assessment
  • Microsoft Office proficiency

Nice-to-have

  • Cross-functional collaboration ability
  • Strong written and oral communication
  • Positive can-do attitude
  • Experience with medical device industry
  • Continuous improvement mindset

Key Requirements

  • Minimum bachelor's degree required
  • At least 1 year relevant experience
  • Knowledge of US and International regulations
  • Ability to work independently and collaboratively

Work Rights

Not specified

Tailored Resume

Cover Letter