Quality Assurance Specialist, Designated Complaint Unit (Americas) - Hybrid

WSA Americas • Woodbridge Township, NJ

30d • $70,000 - $90,000 • Hybrid

About The Position

WSA is a global leader in the hearing aid industry. Together with our 12,000 colleagues in 130 countries, we invite you to help unlock human potential by bringing back hearing for millions of people around the world. Our portfolio of technologies spans the full spectrum of hearing care, from distinct hearing brands and digital platforms to managed care, hearing centers and diagnostics locations.

Requirements

• Bachelor’s degree required
• Experience or knowledge with Complaint Handling processes and associated standards and regulations (FDA, ISO 13485, CFR, GMP, etc.) preferred
• Proficient with Microsoft Office tools (Excel, PowerPoint, Word).
• Salesforce and/or Complaint Management System experience preferred
• Possess leadership capabilities
• Strong problem-solving and time management skills
• Team player
• Ability to work independently

Nice To Haves

• Experience or knowledge with Complaint Handling processes and associated standards and regulations (FDA, ISO 13485, CFR, GMP, etc.) preferred
• Salesforce and/or Complaint Management System experience preferred

Responsibilities

• Serve as part of the America’s DCU working in a Global and multicultural Team that ensures customer complaints are captured, assessed for reportability, processed and resolved in a timely manner as per applicable internal and regulatory requirements.
• Perform initial screening of new complaints to determine potential reportability, investigator and appropriate investigation location. Process local device return logistics for complaint handling.
• Perform follow-ups with investigators, LPOC’s and other partners to ensure complaints are processed in a timely manner.
• Continuously review complaint files to ensure documentation is aligned according to requirements (internal/external) and good documentation practices.
• Perform final review of complaint files to ensure all activities were completed and documented accordingly.
• Provide input on Global Projects and process improvements related to complaint handling.
• Provide support for stakeholders and ensure that Global complaint process inspections and audits (internal and external) are effectively managed.
• Serve as a contact person to local Customer Service, Affiliates and LPOC’s to ensure all appropriate complaint information is received for day-to-day complaint handling.
• Be available for early morning calls with global Team 1-2x per month.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level