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KARL STORZ Logo KARL STORZ · IT - Administration

Product Safety & Vigilance Specialist

United States, El Segundo 82400.00 - 100000.00 USD / Year · Job Posted April 16, 2026
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Job Description

We are seeking a Product Safety & Vigilance Specialist to help identify, assess, and mitigate real and potential product safety risks across our medical device portfolio. In this role, you will serve as a subject matter expert in complaint management and medical device reporting, partnering closely with global teams, regulatory authorities, and internal stakeholders to ensure compliance, continuous improvement, and patient protection.

Job Responsibility

  • Lead investigation and assessment of potentially reportable product safety events (MDRs) and complaints
  • Collect, analyze, and document product surveillance data to identify trends, risks, and opportunities for corrective action
  • Review product complaints related to quality, safety, and performance
  • conduct interviews and device history reviews as needed
  • Coordinate cross‑functional activities including failure analysis, CAPA, nonconformance, and root cause investigations
  • Develop and implement proactive risk minimization and benefit–risk assessment plans
  • Ensure complete, accurate, and timely documentation through investigation closure
  • Support Field Safety Corrective Actions (FSCA) and multi-site product safety initiatives
  • Communicate clearly and professionally with regulatory agencies and authorities
  • Support FDA, ISO, and third‑party audits and follow up on corrective and preventive actions

Requirements

  • 3–5 years of experience in a highly regulated environment (medical device or pharma strongly preferred)
  • Hands-on experience in Product Safety, Vigilance, Quality, or Product Surveillance
  • Bachelor’s degree or equivalent combination of education and experience
  • Strong working knowledge of MS Office
  • experience with SAP/R3 preferred
  • Excellent communication, collaboration, and conflict-resolution skills
  • High sense of ownership, accountability, and solution-oriented mindset

Nice to have

  • 5+ years of relevant industry experience
  • Background or training as a healthcare professional or in medical/scientific disciplines

What we offer

  • Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance
  • 3 weeks vacation, 11 holidays plus paid sick time
  • Up to 8 weeks of 100% paid company parental leave
  • includes maternal/ paternal leave, adoption, and fostering of a child
  • 401(k) retirement savings plan providing a match of 60% of the employee’s first 6% contribution (up to IRS limits)
  • Section 125 Flexible Spending Accounts
  • Life, STD, LTD & LTC Insurance
  • Tuition pre-imbursement up to $5,250 per year
  • Fitness reimbursement of up to $200 annually
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