Post Market Surveillance Engineer Ii

The Integer Group

Base salary not specified; cash-based incentive pr...
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Bachelor's degree or 3 years experience
Fda 21 cfr qsr compliance knowledge
Complaint investigation and root cause analysis
** The Integer Group is seeking a Post Market Surveillance Engineer II to manage complaint handling, regulatory reporting, and post-market surveillance processes while adhering to FDA regulations and internal policies. The role emphasizes collaboration, continuous improvement, and commitment to quality within the medical device sector. **

Job Summary

  • The primary purpose of this role is to execute complaint handling, regulatory reporting, and post-market surveillance processes to ensure FDA compliance.
  • Candidates will perform root cause investigations, risk assessments, and CAPA activities while collaborating with cross-functional teams to protect patient safety.
  • The company offers a comprehensive benefits package including immediate eligibility for medical, dental, vision, life insurance, and a 401(k) plan with matching contributions.

Matching Summary

Match Score: 75

** The Integer Group is seeking a Post Market Surveillance Engineer II to manage complaint handling, regulatory reporting, and post-market surveillance processes while adhering to FDA regulations and internal policies. The role emphasizes collaboration, continuous improvement, and commitment to quality within the medical device sector. **

Salary

Base salary not specified; Cash-based incentive program available; Comprehensive benefits package with immediate eligibility

Skills & Requirements

Must-have

  • Bachelor's degree or 3 years experience
  • FDA 21 CFR QSR compliance knowledge
  • Complaint investigation and root cause analysis
  • CAPA assessment and implementation skills
  • Adverse event reportability decision making

Nice-to-have

  • Cross-functional collaboration abilities
  • Microsoft Office advanced proficiency
  • 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

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