Danaher Corporation Complaint Specialist in Carlsbad, California
In our line of work, life isn’t a given - it’s the ultimate goal. When life takes an unexpected turn, our technology and solutions enable caregivers to make informed diagnostic decisions to improve patient care. This is our shared purpose at Radiometer and what unites all +4000 of us - no matter our roles or where in the world we’re located. Creating impactful innovations like ours, doesn’t happen overnight - it requires uncompromising persistency, passion, and a desire to make a difference. Here, you can learn, grow, and chart an uncommonly diverse career.
Radiometer is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.
The complaint specialist is responsible for receiving, reviewing, and processing all product complaints for company manufactured products as required by internal procedures and in accordance with regulatory requirements. The position will work with field personnel for the identification and resolution of customer complaints. The complaint specialist will evaluate each complaint and ensure proper and timely handling.
All the responsibilities we will trust you with:
Receiving, reviewing, and processing global product complaints while using GDP
Processing complaints through classification of complaints, contact and product follow ups, maintaining investigation records and all other supporting documentation, and complete/assign additional actions as necessary to close the complaint.
Ensure complaints are processed thoroughly and in a timely manner in compliance with internal procedures and metrics.
Evaluate the complaints for potential health hazard and determine if complaints require escalation.
Ensure complaints requiring contact responses are properly addressed and response is documented in the complaint file.
Request information from the contact/field related to complaint including the return of product(s).
Review’s complaint investigation to ensure investigations meet procedural requirements
Participate in CAPAs required by trending/metric alert actions
Report trending/metrics as required and in a timely manner.
Optimize complaint handling procedures in accordance with regulatory requirements
Participate in global process improvement projects and learn from best practices in DHR/Radiometer/Industry.
Perform additional duties as assigned.
Requirements and Preferred Qualifications
2 plus years complaint handling experience in a medical device establishment preferred
Preferred ability to apply FDA 21 CFR 820, ISO 13485 and other relevant regulation relating to complaint processing
Ability to learn other software quickly as required.
Must be detail oriented. Able to detect errors and ensure accuracy of complaint file documents and analyses.
Critical thinking and strong problem-solving skills
Ability to prioritize and work independently or within a team
Excellent verbal/written communication skills required
BS/BA in Science or Engineering preferred
Proficient computer skills and knowledge of relevant business applications, Internet, Microsoft Office applications.
- General physical requirements: Requires lifting up to 25 pounds
- Up to 5-10% may be required including international travel
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.
Danaher is committed to a diverse and inclusive culture where everyone feels they belong, and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.
If you’ve ever wondered what’s within you, there’s no better time to find out.
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.
Danaher Corporation and all Danaher Companies require all US and Puerto Rico employees to be vaccinated against COVID–19 as a condition of employment, subject to reasonable accommodation as required by law.
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at email@example.com to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.