FREE ACCESS
5,000–10,000 jobs/day
See all jobs on JobTailor
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
QARA Complaints Specialist
Dentsply SironaQARA Complaint Specialist ensuring timely handling of product complaints at Wellspect medical device company. Collaborating for regulatory compliance and enhancing product quality.
About the role
Key responsibilities & impact- Serves as the primary complaint initiator for the Wellspect US Complaint Handling team.
- Receives, evaluates, codifies, and documents product complaints accurately in the designated complaint management system, ensuring all required data is captured in a timely and compliant manner.
- Conducts follow-up communication with complainants to support complaint investigations and gather additional information as needed.
- Provides regular updates on complaint status and, when applicable, communicate final investigation findings to the complainant in a professional and empathetic manner.
- Ensures all complaint-handling activities are performed in accordance with applicable US regulations and standards, including but not limited to 21 CFR 820, 21 CFR 803, ISO 13485:2016, etc.
- Adheres to internal policies, SOPs, and quality system requirements.
- Contributes to the investigation process by collaborating with internal teams and supporting documentation efforts.
- Participates in root cause analysis and recommend next steps as appropriate.
- Supports the implementation of corrective or preventive actions stemming from complaint data, helping to reduce the likelihood of recurrence.
- Assists in tracking and trending complaint data.
- Prepares reports and contribute data insights to support ongoing quality improvement initiatives.
- Provides guidance and share best practices with internal teams on complaint handling processes.
- Supports onboarding and training of new team members as needed.
- Partners with teams such as Engineering, Manufacturing, Regulatory Affairs, Field Sales Call Center Operations and Customer Service to resolve complaints effectively and drive continuous improvement.
- Performs other responsibilities as assigned in support of team and departmental goals.
Requirements
What you’ll need- Bachelor’s degree in a scientific, technical, or healthcare-related discipline required.
- 3+ years of experience in a customer-facing or highly regulated role preferred.
- Experience in a medical device, pharmaceutical, or other life sciences industry is a strong plus.
- Proficient in English; strong written and verbal communication skills required.
- Multilingual abilities are highly desirable.
- Excellent organizational skills and a high degree of attention to detail are fundamental to success.
- Strong comfort level with computer-based tasks, including working across multiple systems or screens simultaneously.
- Proficiency in standard office software (e.g., Microsoft Office Suite); experience with electronic quality or complaint management systems preferred.
- Able to work both independently and collaboratively in a fast-paced, team-oriented environment.
Benefits
Comp & perks- 401(k) matching
- Wellness programs
- Professional development opportunities
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
complaint managementroot cause analysisdata analysisquality improvementregulatory complianceISO 13485:201621 CFR 82021 CFR 803documentationcustomer service
Soft Skills
communicationorganizational skillsattention to detailempathycollaborationtrainingproblem-solvingindependenceteamworkmultilingual abilities