CQA Audiologist

Quality Assurance              ·              Valencia (CA), United States              ·           Full time

You enjoy creating and innovating. You never stop striving for better. You take responsibility and you get results. You love being part of a team. Above all, you want your work to matter: Welcome to our world! At Sonova we create sense by bringing sound to life. Our innovative hearing care solutions help millions of people enjoy life’s unforgettable moments.

We offer exceptional career opportunities through market-leading brands from consumer to medical, products and services that keep pushing hearing care forward, and a culture where you can quickly belong and perform at your best.

If you want the freedom to explore, opportunities to grow, and make positive change on people lives through your work, this is the place for you.

Join Sonova. Create sense.

Valencia (CA), United States

CQA Audiologist

Overview

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 and monitor 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 Manager Global Complaint Handling under Advanced Bionics’ Global Quality System department based in Valencia, California.

What you’ll do:

• Monitor new complaints and all updates to complaints for: thoroughness, clarity, accuracy, reportability, movement towards closure and reportability.
• 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.
• 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.
• Other duties as assigned.

What you bring to the team:

• Education: Master’s Degree in Audiology
  • Nice to Have: Doctorate of Audiology preferred
• Work Experience:  5+ years in a GMP, QSR, and ISO regulated medical device, or clinical diagnostic, industry.
  • Nice to Have: Preferably, experience in a cochlear implant clinical setting.
• Personal Competencies: Team player; Successful track record in multi-tasking in a fast-past environment
• Social  Competencies: Effective and professional communication skills, verbally and in writing.
• Professional Competencies: Strong clinical background with knowledge and experience with Cochlear implant systems and understanding of the field of audiology.
• Language(s)/ Level: English/ Fluent
  • Nice to Have: Second Language  
• IT Skills: Proficiency with MS Outlook, Word, Excel, PowerPoint, Access, SalesForce, SAP and SQL; Experience with reporting systems

Our offer:

• Exciting and challenging work environment
• Comprehensive benefits package
• Training and development opportunities – we believe every employee deserves a development plan. Come, learn, and grow with us!

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

We love to work with great people and strongly believe that a diverse team makes us better.  We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of race, color, creed/religion, sex, sexual orientation, marital status, age, mental or physical disability.

We thank all applicants in advance; however only individuals selected for an interview will be contacted.  All applications will be kept confidential. Sonova is an equal opportunity employer. Applicants who require reasonable accommodation to complete the application and/or interview process should notify the Senior Manager, Human Resources.

Pay Ranges (SoCal): $70,000/yr – $75,000/yr

Health Benefits & 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
• Short/Long-Term Disability coverage (STD/LTD)
  • STD LTD Buy-ups available
• Accident/Hospital Indemnity coverage
• Legal/ID Theft Assistance
• PTO & paid holidays*
• Employee Assistance Program

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

Sonova is an equal opportunity employer

We team up. We grow talent. We collaborate with people of diverse backgrounds to win with the best team in the market place. We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of a candidate’s ethnic or national origin, religion, sexual orientation or marital status, gender, genetic identity, age, disability or any other legally protected status.

Please click here to apply.