Hearing Solutions Quality Specialist

16 hours ago


Ballerup, Ballerup Kommune, Denmark GN Store Nord AS Full time

Role Overview

The Associate Customer Solutions Specialist role is a key position within our organization, encompassing two main components: complaint investigation and coordination. This role requires strong analytical and communication skills to effectively conduct investigations, coordinate results, and drive product and customer quality improvements.

Key Responsibilities:

  1. Conduct thorough investigations of devices with alleged deficiencies reported through customer complaints in Salesforce.
  2. Coordinate investigation results to internal and external teams, ensuring timely and effective resolution.
  3. Work with cross-functional teams to ensure complaint cases are complete with accurate information for in-depth investigation.
  4. Evaluate and troubleshoot devices/accessories to determine the root cause of complaints and collaborate with Operations to resolve.
  5. Fulfill customer expectations by providing prompt and informative responses to complaints.
  6. Understand and adhere to regulatory requirements (FDA Regulations, ISO 13485) for complaint handling.
  7. Perform electro-acoustical analysis on device hardware and interpret test results.
  8. Interface with manufacturing supervisors and leads to discuss process and product improvements.
  9. Organize and arrange intercompany complaint shipments as needed.
  10. Monitor and review monthly customer feedback cases to identify trends and areas for improvement.

Requirements:

  • Quality Systems knowledge (preferably in medical devices)
  • Familiarity with ISO quality standards (ISO 13485) and FDA CFR 820
  • Proficiency in Microsoft Office: Excel, Word, PowerPoint, Outlook, Teams
  • Experience with Salesforce (preferred)
  • Excellent oral and written communication skills and interpersonal skills to interact with cross-functional teams
  • Able to work independently and prioritize tasks effectively
  • Strong organizational skills for document maintenance and storage

Benefits:

  • Generous benefits package including PTO and paid holidays
  • 401k plan with company match
  • Paid parental leave and transition back to work benefits
  • Company HSA contributions
  • Free hearing aids for family members

About Us:

At GN Store Nord A/S, we empower individuals with hearing loss to live their lives to the fullest. Our innovative solutions transform lives by harnessing the power of sound. We value diversity and inclusion, fostering a collaborative environment that encourages growth and development.



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