Valencia, CA

CQA Audiologist

Purpose of role:The CQA Audiologist will provide clinically-focused support for the Advanced Bionics team of complaint handlers, audiologists and support staff globally who are focused on ensuring regulatory and quality compliance for the complaint handling process, including compliance with 21CFR820, ISO13485, MDSAP and MDR. Review, process monitor and escalate when necessary, new and ongoing Product Complaints, Customer Inquiry, Business, Marketing Feedback and Recipient Death Cases. Work with complaint management specialists to manage Cases efficiently and professionally in accordance with Regulatory requirements and company procedures, assigning follow-up tasks, handle requests for additional follow up information from the field. Interface between various departments to collect relevant information for Case documentation and report trending. Create, maintain and update standard reports on a regular basis. Create ad hoc reports as requested. Provide clinical support to various departments globally as needed.

This position will report into the Sr. Manager Global Complaint Handling under Advanced Bionics' Quality Reliability department based in Valencia, California.

Main Tasks and Responsibilities:

• Monitor new complaints and all updates to complaints for: thoroughness, clarity, accuracy, reportability, movement towards closure and reportability.
• Provide support to Safety Review Board (SRB) to help manage potential safety related complaints, generate regular SRB keyword reports to identify potential SRB related complaints. Study Investigation Review Board (SIRB) and Explant Review Board (ERB) to help manage complex clinical cases.
• Interface between various departments "in-house" e.g., Regulatory Affairs, Quality Assurance, Quality Engineering, Clinical Research, Technical Services, Customer Service, Research and Development, Marketing, Sales etc. and the field staff in order to collect necessary information for case documentation and report trending.
• Process follow-up information from the field, incorporating into the complaint handling system as needed.
• Assign follow up when appropriate in response to Recipient notes that accompany returned equipment.
• Assist in handling requests for complaint information or additional follow-up from various departments. Assist the Field Staff in obtaining information from various departments within the organization.
• Maintain and develop complaint trending reports. Create ad hoc reports, as needed, for Marketing, Clinical Research, Customer Service, Quality, Legal, and Research and Development.
• Provide initial and on-going training and support for users of , RADIUS for Field Staff Users who manage Clinical Complaints, Safety Review Board information and enter Marketing Feedback, Customer Inquiry, Business Cases and Recipient Death Cases. Also training Regional Managers, CICS, Professional Outreach Team members and other personnel on when and how to escalate information to Complaint Management for entry into RADIUS.
• Provide information obtained through documentation in RADIUS to other departments without this visibility, e.g., explant and other sensitive information to Legal, device return status and pending surgery details to Quality Assurance, etc.
• Review complaints and alert various departments of pending explant surgeries. Classify the return reason based on clinical symptoms.
• Ensure all returned internal devices have Case ID #s and necessary information documented within the complaint, i.e., Recipient name, SN, return reason, explant date, RMALI #, etc.
• Review Device Failure Analysis (DFA) reports and interim DFA reports, reviewing for thoroughness, clinical accuracy and continuity with information provided in the clinical complaint, and providing the clinical return reason.
• Provide clinical summaries and symptom timelines for devices that meet specific criteria during failure analysis process.
• Perform review of finalized DFA reports and distribution to field staff personnel for dissemination to clinics. Respond to questions from clinics relating to content of DFA reports as applicable.
• Compile clinical summaries as requested by Legal, Field Staff and Auditory Technical Services departments

Education and Skillset:

• Master's Degree in Audiology required, Doctorate of Audiology preferred
• 5 years in a GMP, QSR, and ISO regulated medical device, or clinical diagnostic, industry
• Experience in a cochlear implant clinical setting preferred
• Strong clinical background with knowledge and experience with Cochlear implant systems and understanding of the field of audiology, experience with Advanced Bionics cochlear implant products preferred
• Team player; Self-starter, Successful track record in multi-tasking in a fast-past environment
• Effective and professional communication skills, verbally and in writing.
• Proficiency with MS Outlook, Word, Excel, PowerPoint, Access, SalesForce, SAP and SQL; Experience with reporting systems
• Nice to have: experience with RADIUS complaint handing system

A minimum of 200Mb/sec download and 10Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality at Sonova

Don't meet all the criteria? If you're willing to go allin and learn we'd love to hear from you!

We are looking forward to receiving your application via our online job application platform. For this position only direct applications will be considered. Sonova does not recruit via app, telegram, carrier pigeon or any other format that does not include speaking with an actual human. If you are offered a job without speaking with someone please contact wholesale.HR@Sonova.com

Health Benefits and Perks:

• Medical, dental and vision coverage*
• Health Savings, Health Reimbursement, Flexible Spending/Dependent Care Accounts
• TeleHealth options
• 401k plan with company match*
• Company paid life/ad&d insurance
  • Additional supplemental life/ad&d coverage available
• Company paid Short/Long-Term Disability coverage (STD/LTD)
  • STD LTD Buy-ups available
• Accident/Hospital Indemnity coverage
• Legal/ID Theft Assistance
• PTO, floating Diversity Day, & paid holidays*
• Paid parental bonding leave
• Employee Assistance Program (24/7 mental health support hotline, 5 company paid counseling sessions and more)
• Robust Internal Career Growth opportunities
• Tuition reimbursement
• Hearing aid discount for employees and family
• Internal social recognition platform
• D&I focused: D&I council and employee resource groups

*Plan rules/offerings dependent upon group Company/location.

If the applicant selected for this role resides in CA, CO, NY or WA we adhere to the pay transparency required in those states. This role's pay range is between: $74,400 - $80,000. This role is also bonus eligible.

How we work

At Sonova we value our employees and prioritize their well-being. We believe people do their best and most innovative work in an inclusive environment that provides opportunities for engagement and collaboration across teams while offering flexibility in how work gets done. We designed our work model team by team, empowering teams to customize a working environment that balances individual team needs with business outcomes. By offering work options, we foster more flexible and individualized time management, contribute to a healthy work-life integration, increase employee satisfaction, build meaningful partnerships at work, and calibrate productivity to acknowledge you have a life outside of work. Sonova has chosen a HYBRID WORK MODEL- Customized by team that keeps our employees motivated and engaged.