Technical Solutions Professional

1 month ago

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

Company Overview

At GN Store Nord A/S, we empower people with hearing loss to hear more, do more, and be more through the power of sound. As a leading medical device manufacturer, we value our employees and offer competitive wages and benefits.

Job Summary

We are seeking a Technical Solutions Professional - Quality Assurance to join our team in MN, Bloomington. This role will encompass two main components: conducting investigations of devices with alleged deficiencies reported through customer complaints and coordinating investigation results to internal and external teams.

Key Responsibilities

  • Work with customer-facing teams to ensure complaint cases are complete with accurate information for in-depth investigations.
  • Conduct complaint investigations related to hardware, software, and system components and provide structured insights to drive product and customer quality improvements.
  • Evaluate and troubleshoot devices/accessories to determine the root cause of complaints and work with Operations to resolve.
  • Manage new orders received in Product Quality by maintaining proper documentation and organization.
  • Fulfill customer expectations through complaint responsiveness in a timely manner and provide feedback when requested.
  • Understand and follow requirements (FDA Regulations, ISO 13485, etc.) for complaint handling.
  • Perform electro-acoustical analysis on device hardware and interpret test results.
  • Interface with manufacturing supervisors and leads to discuss process and product improvements.
  • Organize, plan, and arrange intercompany complaint shipments.
  • Review and monitor monthly customer feedback cases.
  • Maintain customer-centricity and a quality mindset in all tasks.

Requirements

  • Quality Systems knowledge (preferred)
  • Familiarity with ISO quality standards (ISO 13485 preferred)
  • Familiarity with FDA CFR 820
  • Proficient in Microsoft Office: Excel, Word, PowerPoint, Outlook, Teams
  • Proficient in Salesforce (preferred)
  • Strong oral and written communication skills and interpersonal skills necessary to interact with cross-functional teams
  • Capable of working independently
  • Excellent organizational skills for document maintenance and storage
  • Excellent internal and external communication skills

Preferred Qualifications

  • Bachelor's degree in a technical or health-related field
  • 1-2 years in complaint management/investigations or technical support in med-tech or hi-tech consumer technology industries
  • Experience or interest in hearing instruments, accessories, programming, and fitting software
  • Clinical experience is considered a plus

Benefits

We offer competitive wages and benefits including:
- Generous Benefits including PTO and Paid Holidays
- 401k with Company match
- Paid Parental Leave & Transition Back to Work Benefits
- Company HSA Contributions
- Free Hearing Aids for Family Members

Estimated Salary

$70,000 - $90,000 per year, depending on qualifications and experience.

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