Post Market Surveillance Engineer Ii

Integer

Base salary not specified; cash-based incentive pr...
Not specified
Fda 21 cfr qsr compliance knowledge
Complaint investigation and analysis skills
Root cause investigation execution
Integer is seeking a Post Market Surveillance Engineer II to support complaint handling, regulatory reporting, and post-market surveillance processes. The ideal candidate should possess a relevant degree, have experience in a regulated industry, and demonstrate strong collaboration and communication skills

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 root cause investigations and risk assessments.
  • The company offers a comprehensive benefits package including medical, dental, vision, disability, life insurance, and immediate 401(k) matching.

Matching Summary

Match Score: 75

Integer is seeking a Post Market Surveillance Engineer II to support complaint handling, regulatory reporting, and post-market surveillance processes. The ideal candidate should possess a relevant degree, have experience in a regulated industry, and demonstrate strong collaboration and communication skills.

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 skills
  • Root cause investigation execution
  • CAPA assessment and support experience
  • Adverse event reportability assessment
  • Microsoft Office proficiency (Excel, PowerPoint)
  • Cross-functional collaboration abilities

Nice-to-have

  • Positive can-do attitude
  • Continuous improvement ideation
  • 5 Sigma quality journey participation
  • Hoshin Planning involvement
  • Visual controls and 5S adoption
  • Standardized problem solving methodologies

Key Requirements

  • Bachelor's degree required or 3 years relevant experience
  • Minimum 1 year of relevant experience in medical device or regulated industry
  • Intermediate to advanced Microsoft Office skills

Work Rights

Not specified

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