Product Safety & Vigilance Specialist
KARL STORZ SE & Co. KG, El Segundo, CA, United States
Every day our products and services help to save lives around the globe. Therefore, we make quality and reliability our number one priority.
Get to know us and join our team.
Product Safety & Vigilance Specialist
Job Function: Patient Health & Regulatory Affairs
Location: El Segundo, CA, US 90245; Auburn, MA, US 01501
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.
What You’ll Do
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
What You Bring
Required
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
Preferred
5+ years of relevant industry experience
Background or training as a healthcare professional or in medical/scientific disciplines
Why Join Us
Directly contribute to patient safety and regulatory excellence
Collaborate with global experts in a cross‑functional, mission‑driven environment
Grow your expertise within a complex and evolving regulatory landscape
Benefits
Medical / Dental / Vision including a state‑of‑the‑art wellness program and pet insurance
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‑reimbursement up to $5,250 per year
Fitness reimbursement of up to $200 annually
And more benefits unique to the role
MA Applicants
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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Get to know us and join our team.
Product Safety & Vigilance Specialist
Job Function: Patient Health & Regulatory Affairs
Location: El Segundo, CA, US 90245; Auburn, MA, US 01501
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.
What You’ll Do
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
What You Bring
Required
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
Preferred
5+ years of relevant industry experience
Background or training as a healthcare professional or in medical/scientific disciplines
Why Join Us
Directly contribute to patient safety and regulatory excellence
Collaborate with global experts in a cross‑functional, mission‑driven environment
Grow your expertise within a complex and evolving regulatory landscape
Benefits
Medical / Dental / Vision including a state‑of‑the‑art wellness program and pet insurance
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‑reimbursement up to $5,250 per year
Fitness reimbursement of up to $200 annually
And more benefits unique to the role
MA Applicants
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
#J-18808-Ljbffr