Technical Solutions Professional
1 week ago
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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