Base salary not specified; cash-based incentive pr...
Not specified
Fda 21 cfr qsr compliance knowledge
Complaint investigation and analysis
Root cause investigation execution
The Integer Group is seeking a Post Market Surveillance Engineer II responsible for executing complaint handling, regulatory reporting, and post-market surveillance processes. The ideal candidate will have a background in medical devices or regulated industries, with strong analytical skills and the ability to work collaboratively in a fast-paced environment
Job Summary
The primary purpose of this role is to execute complaint handling, regulatory reporting, and post-market surveillance processes in compliance with FDA 21 CFR (QSR) requirements.
Candidates will be responsible for performing root cause investigations, risk assessments, and CAPA assessments while ensuring timely closure of complaint investigations.
The company offers a comprehensive benefits package including medical, dental, vision, disability, life insurance, and immediate 401(k) matching contributions.
Matching Summary
Match Score: 75
The Integer Group is seeking a Post Market Surveillance Engineer II responsible for executing complaint handling, regulatory reporting, and post-market surveillance processes. The ideal candidate will have a background in medical devices or regulated industries, with strong analytical skills and the ability to work collaboratively in a fast-paced environment.
Salary
Base salary not specified; Cash-based incentive program available; Comprehensive benefits including medical, dental, vision, 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
Nice-to-have
Cross-functional collaboration skills
Strong written and oral communication
Positive can-do attitude
Continuous improvement mindset
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