Job Function: Patient Health & Regulatory Affairs
Location:
El Segundo, CA, US, 90245
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Work Location (for field-based positions):
Work Flexibility: Hybrid
Pay Range:
Job ID: 5657
About KARL STORZ
From the operating room to surgery centers—and everywhere in between—KARL STORZ North America is a global leader in medical technology and advanced visualization solutions. We design specialty innovations, smart instruments and devices, integrated ecosystems, and intelligent imaging—to build a more connected, software-enabled operating room.
As an independent, family-owned MedTech company, we ambitiously think in generations instead of quarters to improve patients’ lives around the world.
About the Role
At KARL STORZ, quality and patient safety are at the core of everything we do. As a Complaint Specialist, you will play a critical role in ensuring product quality and regulatory compliance by managing the full lifecycle of product complaint investigations.
In this position, you will serve as a central point for receiving, evaluating, investigating, and trending product complaints—ensuring they are handled in accordance with FDA regulations and internal procedures. You will collaborate cross-functionally with teams such as Quality, Regulatory, R&D, and Customer Support while contributing to continuous improvement of complaint handling processes.
This role is ideal for a detail-oriented professional with strong analytical skills who is passionate about quality systems, compliance, and improving patient outcomes.
What You’ll Do
Manage end-to-end product complaint investigations, including intake, documentation, evaluation, and closure
Review and assess incoming complaints, assign investigation ownership, and ensure timely resolution
Conduct complaint trending and reporting to identify product or process improvement opportunities
Prepare and submit regulatory reports (e.g., MDR/MPR) in compliance with FDA and global requirements
Collaborate with internal teams and external partners to gather technical information and resolve issues
Support audits and ensure adherence to quality systems, SOPs, and complaint handling procedures
What You Bring
4–6 years of experience in quality, complaint handling, or a related field
High school diploma required; bachelor’s degree or quality certification preferred
Knowledge of FDA regulations, complaint handling guidelines, and quality systems (GMP, ISO)
Experience with SAP or similar systems for complaint tracking and product data
Strong written and verbal communication skills with the ability to document clearly and accurately
Excellent organizational skills with strong attention to detail
Nice to Have:
Experience preparing and submitting MDR/MPR reports
Background in medical device, healthcare, or regulated industries
Familiarity with KARL STORZ products or similar technologies
Experience supporting audits (FDA, ISO, or third-party)
What Will Make You Successful
Strong analytical and problem-solving skills with the ability to evaluate technical information
High level of accuracy and attention to detail when managing sensitive complaint data
Ability to work independently while collaborating effectively across teams
Sound judgment and discretion when handling confidential information
A proactive mindset with a drive for continuous improvement and process optimization
Why KARL STORZ?
Join KARL STORZ and be part of a team dedicated to delivering safe, high-quality medical technologies that improve patient outcomes worldwide. In this role, you’ll contribute directly to product quality and regulatory excellence while working in a collaborative, mission-driven environment.
We invest in our employees’ development and provide opportunities to grow within a global MedTech leader committed to innovation, integrity, and continuous improvement.
Ready to make an impact? Apply to be our next Complaint Specialist and help us build the future of MedTech together.
#LI-AA1
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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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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
[email protected].
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Get in Contact
5657
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Nearest Major Market: Los Angeles
