Sr. Customer Solutions Specialist (Hybrid - Shakopee, MN)

The Sr. Customer Solutions Specialist oversees the management of customer complaint resolution for internal and external clients in North America at GN Hearing. 

Responsible for the overall management of incoming complaint cases, the Sr. Customer Solutions Specialist also provides support to Global Product Quality and direct support and guidance to local NA Product Quality team.

Essential Functions:

• Manage incoming complaint and CCL queues including reviewing new complaint cases to ensure necessary information is included for case investigations, creating parent cases as needed, and assigning complaint cases to parent cases, supervisors, or escalations to Global Product Support (GPS).
• Review NA potential safety complaint cases including monitoring trigger words and patient safety, ensuring inclusion of needed case information, escalations to Regulatory Product Surveillance (RPS) team through Sales Force (SF) and case closures.
• Ensure that customer and internal company complaints for NA business channels are compliant with FDA and ISO 13485 requirements, including categorization, descriptions of alleged deficiency and collection/inclusion of required case information. Review complaint cases after investigation to ensure compliance and participate and represent complaint cases for internal and external audits.
• Review the diagnoses on customer complaints and discuss individual cases with investigators as needed, interface with manufacturing supervisors and leads to discuss process/product improvements.
• Ensure proper routing and tracking of open US complaints cases to appropriate teams (XMN, JB, RPS, etc.), providing visibility and facilitating progress toward effective and timely case processing and closure at 30+, 60+ and 90+ day increments.
• Daily support to Customer Care, Tech Support, Order Entry, Sales, Customer Advisors, Operations, and other departments as needed with follow-up on open and escalated complaint issues, training, SFDC support and investigation results either through letters, digital pictures, or phone calls.
• Track and report service failures or potential service failures and work with other departments to identify/implement cross-functional solutions to prevent future, ongoing failures.
• Support and participate in Hypercare initiatives in support of new launches, including complaint investigations and symptom verification, team logistics, TFS case creation if needed, data collection and visualizations.
• Support and assist Operations in troubleshooting and diagnosis validation of multiple repairs, creating and addressing CAPAs and NCs, and training development for production personnel on Sales Force, complaint processes and use of FSW and other relevant tools and information.
• Support relevant and complaint related SFDC projects as needed.
• Participate in meetings for NA Product Quality including VOC and XMN complaint handling meetings as needed.
• Internally Outsource Process review.

Skills and Knowledge Needed:

• Dedicated to understanding customer needs while focusing on meaningful outcomes.
• Advanced critical thinking and effective problem-resolution skills.
• Organized and practical with a notable capacity to recognize and enhance customer quality through data-informed and evidence-based methods.
• Proficiency using tools such as Microsoft Office, Excel, Word and Power Point, Outlook, Access, Navision, and Salesforce.
• Familiarity with ISO quality standards. Working knowledge of relevant regulations and standards (FDA 21 CFR Part 820/QSR, ISO 13485, EU MDR or equivalent).
• Ability to work well and engage with others in a team environment, as well as effectively managing one's own tasks.
• Determined and inquisitive. Often surpasses standards and addresses challenges with optimism.
• Demonstrates the ability to perform effectively within demanding circumstances and limited timeframes, showcasing proficient time management abilities.
• Highly organized and results driven.
• Proficient in both spoken and written communication, with the interpersonal skills required to collaborate with directors and managers.

Qualifications:

Education:

• Bachelor’s degree in a technical or health related field and/or equivalent experience (Required).

Experience:

• 5+ years’ experience in complaint handling systems, customer solutions, and product quality in a regulated industry.
• Hearing device experience recommended, medical devices or regulated consumer electronics.
• Comprehensive management of end-to-end complaint case management (intake → triage → investigation → documentation → c