Product Complaint Support Rep

Fresenius Kabi USA, LLC; Street; On-site; GBP 60,000 - 80,000; Full time

Job summary

Ein etabliertes Unternehmen im Bereich Medizintechnik sucht einen engagierten Fachmann für Qualitätsmanagement, der als erste Anlaufstelle für qualitätsbezogene Produktbeschwerden fungiert. In dieser spannenden Rolle sind Sie verantwortlich für die Bearbeitung von Kundenanfragen, die Dokumentation von Beschwerden und die Zusammenarbeit mit verschiedenen Teams zur Sicherstellung der Qualität. Sie werden Teil eines dynamischen Teams, das sich der kontinuierlichen Verbesserung und der Einhaltung von Vorschriften widmet. Wenn Sie eine Leidenschaft für Kundenservice und Qualitätsmanagement haben, ist dies die perfekte Gelegenheit für Sie.

Benefits

Medizinische Versorgung

Zahnversicherung

Sehversicherung

Lebensversicherung

Invaliditätsversicherung

401K mit Unternehmensbeitrag

Wellness-Programme

Qualifications

• 1-3 Jahre Erfahrung im Kundenservice und/oder Qualitätsmanagement.
• Kenntnisse der FDA-Qualitätssysteme und medizinischen Berichterstattung sind von Vorteil.

Responsibilities

• Verwaltung des Workflows für qualitätsbezogene Anfragen.
• Dokumentation von Beschwerdeinformationen im gCMW-System.

Skills

Kundenservice

Qualitätsmanagement

SAP

Analytische Fähigkeiten

Kommunikationsfähigkeiten

Organisationsfähigkeiten

Problemlösungsfähigkeiten

Education

Bachelor-Abschluss

Tools

SAP

Word

Excel

Job description

Job Summary

This position is customer facing and acts as the first point of contact for all quality-related product defects within MedTech for Region North America. It supports the timely and accurate processing of customer complaints to ensure compliance with regulatory obligations and to meet customer needs. The role serves as the primary contact for customers and the Medical Device Commercial Organization regarding quality-related complaints.

Salary Range: $23.45 to $27.00 per hour
Final pay determinations depend on factors such as experience, education, knowledge, skills, and abilities. Our benefits are comprehensive, designed to support colleagues' health and well-being.

Responsibilities

1. Manage workflow for all quality-related inquiries (internal and external).
2. Evaluate initial complaints for investigation needs within the Global Complaint Management Workflow (gCMW).
3. Document complaint information in gCMW, including necessary details like sample and root cause information.
4. Follow up with customers to gather required information as per Standard Operating Procedures or as requested by Post Market Quality Assurance, including sample retrieval and tracking.
5. Coordinate product returns with Post Market Quality Assurance and Customer Service.
6. Assess and authorize customer credits when applicable. Respond to customers promptly with receipt acknowledgment, status updates, and final evaluations.
7. Attend product-specific monthly review meetings and report updates to the MedTech Commercial Organization.
8. Escalate complaints to the internal commercial team for awareness and support.
9. Process data requests from the commercial team, including complaint details and credit reports.
10. Generate reports to aid customer support responses.
11. Participate in customer meetings and escalate feedback on quality processes as needed.
12. Collaborate with Quality Assurance and Engineers on trend analysis, investigations, and process improvements.
13. Assist in investigating high-risk complaints with the Divisional Post Market Quality Assurance Team and Product Line Quality Engineers.
14. Ensure compliance with company policies regarding health, safety, environment, energy, and quality management systems.

Requirements

• Bachelor's Degree preferred.
• SAP experience is preferred.
• 1-3 years of customer-facing and/or quality-related experience preferred. Knowledge of FDA Quality Systems and Medical Device Reporting regulations (21 CFR 803, 820 & 211; Part 11) is a plus.
• Ability to prioritize multiple projects to ensure compliance.
• Excellent communication and organizational skills.
• Strong problem-solving and analytical skills.
• Flexibility to work on new products and assignments.
• Proficiency in Word and Excel.
• Strong interpersonal skills and ability to work cross-functionally.
• Self-motivated and quick learner.
• Exceptional customer service skills.

Additional Information

We offer a competitive salary and benefits package, including medical, dental, vision coverage, life insurance, disability, 401K with company contribution, and wellness programs.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration regardless of race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or veteran status.