Product Safety & Vigilance Specialist

Product Safety & Vigilance Specialist El Segundo, CA Job Details $82,400 - $100,000 a year 1 day ago Benefits Wellness program Paid holidays Disability insurance Health insurance Dental insurance Flexible spending account Adoption assistance Parental leave Vision insurance 401(k) matching Gym membership Life insurance Paid sick time Pet insurance Qualifications Microsoft Office Conflict management

Full Job Description Job Function:

Patient Health & Regulatory Affairs Location:

El Segundo, CA, US, 90245 Auburn, MA, US, 01501 Work Location (for field-based positions):

Work Flexibility:

Hybrid Pay Range:

$82,400 - $100,000

Job ID:

5355 Make an impact on patient safety. 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 Who we are

KARL STORZ

is an independent, family-owned company headquartered in Germany's renowned MedTech manufacturing region. For 80 years, we've pioneered the most groundbreaking innovations in endoscopic surgery, video imaging, and operating room integration to benefit patients and healthcare providers alike. With more than 9,000 associates worldwide and 2,600 in the US, we pride ourselves on harnessing cutting-edge technology, precise workmanship, and unrivaled customer support to help healthcare facilities succeed. With onsite locations and field opportunities across the country, we attract a diverse and talented staff. It's not just about the tools we create—it's about the lives we change, together. #

LI-CW1 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. Eligible Employee Benefits Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance, too! 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 We prepay your tuition up to $5,250 per year! - Tuition pre-imbursement Fitness reimbursement of up to $200 annually And much more!

KARL STORZ

reserves the right to change or modify the employee's job description whether orally or in writing, at any time during the employment relationship. Additionally, KARL STORZ, through its supervisors, may require an employee to perform duties outside their normal description within the sole discretion of the supervisor. Employees must comply will all applicable

KARL STORZ

policies and procedures.

KARL STORZ

is committed to creating an inclusive space where employees are valued for their skills and unique experiences. To achieve this goal, we are committed to diverse voices, and all applicants will receive consideration without regard to race, color, sex, national origin, disability, veteran status, or any other protected characteristic.

KARL STORZ

is also committed to providing reasonable accommodations during our recruitment process. Should you need assistance or accommodation please email us at . Get in Contact 5355

Nearest Major Market:

Los Angeles