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Who we are

In a life without sound, our work provides meaning. As a leading provider of innovative hearing care solutions, we are not just a company that makes products: we are a team on a mission to help people enjoy the delight of hearing. To enable a life without limitations, we – through our core business brands Phonak, Unitron, Hansaton, Advanced Bionics and AudioNova – develop, manufacture and distribute solutions that push the limits of technology and redefine the future of our industry.

Valencia (CA), United States

Sr. Quality Analyst

What you’ll do:

 

Responsible for collecting, recording, reviewing, reporting, and analysis of data on the quality, performance and safety of Advanced Bionics’ devices for the Post-Market Quality department and reporting to applicable notified bodies.

This position will capture Post Market Surveillance documentation in a manner which is proportionate to the risk class and appropriate for the type of device.  Updating documentation continuously for all device types in a clear, organized readily searchable, unambiguous manner and deliver the information to drive key decisions to help build the analytics roadmap for the Global Quality organization. 

 

•        Utilize multiple data sources to identify trends to ensure compliance with post-market regulations

•        Create dashboards and reports to communicate key metrics

•        Create relevant plans and reports for all approved devices or systems as required to document results and conclusions to ensure compliance with post-market regulations

•        Support investigation teams through analysis of data and trends

•        Present insights from trends and investigations to senior leadership to identify when projects need to be initiated

•        Ensure data integrity is maintained across multiple systems

•        Submission of reports and maintenance of Technical Documentation

•        Collaboration with various teams to ensure appropriate data inputs are received and analyzed in a timely manner to meet requirements

•        Complete projects as assigned by department leadership to support organization initiatives

 

What you bring to the team:

    

Bachelor’s degree in a Science, Math, or Engineering or other related fields   

Minimum of 3 to 5 years in Medical Device field.  Knowledge of FDA, EU MDR, MDSAP Regulations and ISO 13485:2016 requirements      

Ability to work within a team and as an individual contributor in a fast-paced

Strong organizational and follow-up skills, as well as attention to detail

Effectively multitasks, prioritizes, and meets timelines     

Strong written and oral communication skills

Good problem-solving skills

Fluent English       

Nice to have; Second Language

Microsoft Office Suite, including Word, Excel, PowerPoint with electronic quality management systems and ERP 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 Director, Human Resources.

 

 

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.