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Who we are

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

CAPA Quality Analyst Engineer

Covid Protocol:

Upholding the company values is extremely important to Sonova, we take the health and safety of our employees, patients, customers and their families very seriously. To that end, we have concluded that the best way to ensure the safety of these individuals is to mandate that all our newly hired employees be fully vaccinated for COVID-19. Therefore, when considering whether to apply for this position, please know that in order to become employed by Sonova (if otherwise eligible), you must provide satisfactory proof, such as a vaccine card or other documentation, that you are fully vaccinated for COVID-19. You will not be required to provide this proof unless and until you receive a formal job offer from Sonova. Please also know that Sonova will provide accommodations to qualified individuals who cannot receive the COVID-19 vaccination because of a sincerely held religious belief or due to a medical issue or pregnancy.

 

Overview

 

Manage and take ownership of the CAPA processes for Advanced Bionics globally.  Lead/participate in other quality system projects as directed by department leadership. 

 

 

What you’ll do:

  • Lead the global corrective and preventive action system to ensure products and processes are continually improved, in particular leading investigation activities, risk evaluations and any required containment or remediation activities. Supporting the global CAPA process.  May need to occasionally accommodate various time zones by having a flexible workday.
  • Ensure CAPA activities for AB global quality system are conducted in a timely and effective manner by engaging resources throughout the organization.  This includes driving and motivating others to take actions, working with various departments to ensure resources are available to address CAPA activities based on quality and business priorities, and working with responsible individuals for thorough and accurate investigation, developing root cause analysis using tools such as 8D, 5 Whys, Fishbone, DMAIC, etc.  Documenting  corrective and preventive action plans, and verifying effectiveness analysis.
  • Interface with management and peers to assess and improve the adequacy of the processes. This includes but is not limited to the remediation of CAPA and NC deficiencies noted in audits and/or inspections
  • Lead the global corrective and preventive action system to ensure products and processes are continually improved, in particular leading investigation activities, risk evaluations and any required containment or remediation activities. Supporting the global CAPA process.  May need to occasionally accommodate various time zones by having a flexible workday.
  • Ensure CAPA activities for AB global quality system are conducted in a timely and effective manner by engaging resources throughout the organization.  This includes driving and motivating others to take actions, working with various departments to ensure resources are available to address CAPA activities based on quality and business priorities, and working with responsible individuals for thorough and accurate investigation, developing root cause analysis using tools such as 8D, 5 Whys, Fishbone, DMAIC, etc.  Documenting  corrective and preventive action plans, and verifying effectiveness analysis.
  • Interface with management and peers to assess and improve the adequacy of the processes. This includes but is not limited to the remediation of CAPA and NC deficiencies noted in audits and/or inspections
  • Manage the administration of CAPA review board meetings, including the processing of CAPA activities and database management.  Actively participate as a board member for CAPA review board meetings.  Participate in the dissemination of CAPA process outputs and linkage to related processes including Management Review. 
  • Effective CAPA and NCR data analysis and trending presenting the global CAPA process at Management Reviews. 
  • Be responsible for maintaining compliance to the global Quality data metrics analysis, trending and reporting and proactively escalate issues. 
  • Act as the SME for internal and external audits related to the CAPA process.
  • Lead continuous improvement and maintenance of the QMS by maintaining an effective CAPA process.
  • Complete projects as assigned by department leadership to support organization initiatives, including but not limited to:
      • Redlining or writing procedures, processing through change control
      • Conducting and/or participating in FMEA activities
      • Supporting internal audit process, compliance to distributor audit schedule, performing Verification of Effectiveness (VOE) activities for CAPA and audit findings at AB sites globally
      • Development and/or execution of Quality Plans, and provide support for quality system improvement activities.
      • Provide support during FDA, TUV and other regulatory inspections.

 

 

What you bring to the team:

 

Education

  • Bachelor’s Degree (Engineering, or related technical field is preferred)

 

 

Work Experience

  • Minimum of  3-5 years’ experience in medical device industry with experience in day-to-day management of quality system processes in an analytical capacity

 

 

Personal Competencies

  • Good interpersonal skills 
  • Solid organizational and planning skills and ability to work with minimal supervision
  • Excellent critical analytical and problem solving skills, including consistent and effective problem solving, expert knowledge of Root Cause Analysis tools and applicable techniques (A3 problem solving, risk analysis, statistical analysis)  
  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving non-conformances
  • Ability to multi-task and have attention to detail while producing high quality work product

Nice to Have:

  • Familiar with Continuous Improvement methodologies, including Six Sigma and statistical tools for data analysis
  • Lead Auditor Certification

 

 

Social Competencies

  • Must be effective in following up and prompting others to take action
  • Strong communication skills (written and verbal), must be able to write in a manner that effectively communicates complex issues

 

 

Leadership Competencies

  • Ability to lead projects with cross-functional participants to successful end goal

Professional Competencies

  • Good understanding of ISO 13485,  21 CFR 820, MDSAP, EU MDR and other applicable regulations

 

 

Language(s) / Level

  • Fluent English / Proficient

 

 

 

IT skills

  • Microsoft Word, Excel, PowerPoint and Access

 

 

Further Requirements

  • Must have the ability to work onsite and remotely as directed by management.

 

 

 

 

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.