Complaint Specialist

Complaint Specialist

At Wellspect, we develop innovative products and solutions that make a real difference in the lives of people managing continence care needs, empowering them to live each day to the fullest. We are looking for a Complaint Specialist to join our QA/RA team in Molndal, Sweden.

Every day, we strive to maintain the highest quality standards while minimizing the environmental impact of our products. In the role as Complaint Specialist, you will play a vital role in enhancing our product quality and customer satisfaction.

What are we expecting from you?

We are seeking a detail-oriented and highly motivated Complaint Specialist with a strong sense of accountability, excellent communication skills and a desire to grow within the medical industry. You will play a key-role in ensuring timely and accurate disposition, intake and documentation of product complaints and supporting regulatory compliance in a cross functional environment.

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 and highly regulated environment.

Responsibilities:

Customer Communication

• Conduct follow-up communication with complainants to support complaint investigations and gather additional information as needed.
• Provide regular updates on complaint status and, when applicable, communicate final investigation findings to the complainant in a professional and empathetic manner.

Compliance

• Ensure all complaint-handling activities are performed in accordance with applicable global regulations and standards, including but not limited to 21 CFR 820, 21 CFR 803, ISO 13485:2016, and EU MDR (Regulation EU 2017/745).
• Adhere to internal policies, SOPs, and quality system requirements.

Complaint Investigation Support

• Contribute to the investigation process by collaborating with internal teams and supporting documentation efforts.
• Participate in root cause analysis and recommend next steps as appropriate.

Corrective and Preventive Actions (CAPA)

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

Reporting and Trending

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

Cross-Functional Collaboration

• Partner with teams such as Engineering, Manufacturing, Regulatory Affairs, and Customer Service to resolve complaints effectively and drive continuous improvement.

Background / Qualifications:

Education

• Bachelor’s degree in a scientific, technical, or healthcare-related discipline preferred. High School diploma or equivalent required.

Experience

• 3-5 years of experience in a medical device, pharmaceutical, or other highly regulated role required.
• Experience in a customer-facing role is a strong plus.
• Experience with investigative processes and root cause analysis is a strong plus.

Key Skills, Knowledge, and Capabilities:

• Proficient in English; strong written and verbal communication skills required.
• 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.
• Familiarity with regulated environments and an understanding of global regulatory frameworks preferred.

Good to know

Please note that we will review applications continuously, so be sure to send in your application as soon as possible.

We look forward hearing from you!