Quality Assurance Specialist - Designated Complaint Unit - WS Audiology Americas

WSAudiology 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.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Ensure customer complaints are captured, assessed for reportability, processed and resolved in a timely matter as per applicable internal and regulatory requirements.
  
• Play an active part in Internal/External Audits and FDA inspection among the whole region.
  
• Serve as part of the DCU working in Global and multicultural Team that assures customer complaints are captured, assessed for reportability, processed and resolved in a timely matter as per applicable internal and regulatory requirements.
  
• Provide input, carry on Global Projects and improvements related to complaint handling processes.
  
• Serve as a contact person for stakeholders and ensures that Global complaint process inspections and Audits (internal and external) are prepared and covered on local market.
  
• Serve as a contact person to local Customer Service, Affiliates, LPoC to ensure correct information intake and day to day work.
  
• Responsible for local Audits / FDA Inspection as planned. Lead assigned Global/Local complaint processes and projects.
  
• 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/others to ensure complaints are processed in a timely manner.
  
• Continuously review complaint files to ensure documentation is performed according to requirements (internal/external) and in line with GDP needs.
  
• Perform final review of complaint files to ensure all activities were performed and documented accordingly.
  
• Perform final review of complaint files to ensure all activities were performed and documented accordingly.
  
• Be available for early morning calls with global staff 1-2x per month

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 experience preferred
• Possesses leadership capabilities
• Strong problem-solving and time management skills
• Team player
• Ability to work independently

The Company provides equal opportunity to all employees and prospective employees without regard to race, color, creed, religion, national origin, ancestry, sex, age, physical or mental disability, marital status, pregnancy, genetic information, sexual orientation, gender identity, protected veteran or military status, or any other consideration not related to the person’s ability to do the job or otherwise made unlawful by federal, state, or local law.