QARA Complaints Specialist

Requistion ID: 83418 

 

Wellspect Healthcare is a leading global provider of innovative medical devices that help people suffering from urinary retention or chronic constipation. More than 1,000 employees around the world are dedicated to making a difference to people who need our products and services. Wellspect is one of the worlds’ leading manufacturers of intermittent urinary catheters, with LoFric® as the most known brand. As a help to those with chronic or severe constipation Wellspect has developed what likely is the world’s most advanced irrigation system, Navina™, combining a high degree of user convenience, clinical effectiveness and connectivity into one smart system. Wellspect strives to become climate neutral and leave the smallest possible environmental footprint.

 

The company, with headquarters in Mölndal, Sweden, is present in more than 30 countries, and part of Dentsply Sirona, the worlds´ largest manufacturer of professional dental technologies. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY. Visit www.wellspect.com and www.dentsplysirona.com for more information.

 

This role will be based in our Braselton office and requires an on-site presence five days per week.

 

Job Summary:

 

We are seeking a detail-oriented and highly motivated QARA Complaint Specialist to join our Wellspect team. This position plays a key role in ensuring timely and accurate disposition, intake and documentation of product complaints, including the determination and distinction between service, product preference and product complaints.  This role supports regulatory compliance and collaborates across functions to enhance product quality and customer satisfaction. The ideal candidate brings a strong sense of accountability, excellent communication skills, and a desire to grow within the medical device industry.

 

This is an exciting opportunity for an early-career professional who is passionate about quality, regulatory compliance, and customer-centric problem solving within a global organization and highly regulated environment.

 

Responsibilities:

 

Complaint Intake and Documentation

• 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.

 

Customer Communication

• 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.

 

Compliance

• 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.

 

Complaint Investigation Support

• 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.

 

Corrective and Preventive Actions (CAPA)

• Supports the implementation of corrective or preventive actions stemming from complaint data, helping to reduce the likelihood of recurrence.

 

Reporting and Trending

• Assists in tracking and trending complaint data.
• Prepares reports and contribute data insights to support ongoing quality improvement initiatives.

 

Training and Knowledge Sharing

• Provides guidance and share best practices with internal teams on complaint handling processes.
• Supports onboarding and training of new team members as neede