Sr. Quality Engineer, Internal Audit/CAPA

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 of 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.

What you’ll do:

Manage the Advanced Bionics Global Auditing Program.  This includes coordinating and/or executing audits (Internal and External) in accordance with Advanced Bionics Quality System per established auditing procedures. Ensuring audit reports are generated and findings documented, perform follow-up on corrective actions, and administrative tasks required to maintain respective Quality System Records.

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

AUDIT

• Primary lead in managing global internal and distributor audit process.
• Engage third party and internal audit resources as necessary to meet the internal and distributor audit schedule
• Develop annual internal audit schedule to ensure internal and external audits are conducted in accordance with  the approved schedule.
• Develop and maintain distributor audit schedule
• Develop annual audit assessment
• Perform additional focused/spot audits as directed by management
• Ensure audit database and general administration of quality records are maintained to ensure enhancement and improvement of reporting tools for trending audit results.
• Maintain audit procedures, Quality System matrix and other relevant QMS documentation
• Perform trending and analysis based on audit observations and presents to senior management as part of the management review
• Perform Effectiveness Verification assessments for audit findings and CAPAs
• Play a key role in supporting external audits from customers, regulatory agencies and /or any interested third party including preparing all sites for external audits.

CAPA

• 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 data analysis 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.

What you’ll bring:

Education: 

HS diploma, or equivalent (Required)

Bachelor’s Degree (Required) 

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

Required Skills and Abilities: 

Solution-oriented

Self-disciplined with strong time management skills

Strong organizational skills

Self-starter and self-motivated to accomplish company and department objectives  

Excellent communication skills in English (written and verbal)

Must be able to work effectively in teams and be collaborative   

Must be able to lead and drive peers to accomplish common goals (e.g. drive timely closure of corrective actions)

Certified quality auditor by a recognized BOK (e.g. ASQ CQA) (Preferred) 

English – Fluent     Second language

Proficient knowledge of MS Office       

Experience with SAP, SalseForce, other data 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.