Internal Auditor

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Job description

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:

Purpose of the Job To lead 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. Generate audit reports and findings, perform follow-up on corrective actions, and administrative tasks required to maintain respective Quality System Records.

* Develop an annual internal audit schedule
* Conduct internal and external audits in accordance with the approved schedule
* Perform additional focused/spot audits as directed by management
* Communicate before, during, and after audits regarding standards and regulatory requirements, audit scope interview time and observations
* Responsible for ensuring that auditees understand findings and observations in relation to standards and regulatory requirements as indicated within Advanced Bionics Quality Systems
* Prepare audit reports and all associated documents as described on the audit procedures and work instructions
* Maintain audit database and general administration of quality records to ensure enhancement and improvement of reporting tools for trending audit results.
* Maintain audit procedures, Quality System matrix and other relevant QMS documentation
* Write detailed reports on effectiveness of the quality system including; strengths, weaknesses, non-compliances to the applicable standards regulations for Class III Medical Device company
* Ensure audit findings are factual, relevant, accurate, and value added to the company's quality system implementation
* Ensure timely closing of audit findings. Manage responses to findings and/or observations from external audits
* Perform Effectiveness Verification assessments for audit findings and CAPAs
* Perform trending and analysis based on audit observations and presents to senior management as part of the management review
* Conduct annual assessments of the QMS by reviewing the outputs of the various feeder systems (e.g. internal and external audits, CAPAs, etc.) each fiscal year to drive recommendations for the following year
* 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
* Train other internal auditors and subject matter experts, as necessary, in audit principles and techniques
* Other duties as assigned by management

What you'll do:

Basic Education

HS diploma, or equivalent

Further Education Bachelor's Degree M.S. in Engineering, Science or equivalent

Work Experience 5-10 years' experience working in a regulated medical device environment with experience conducting quality system audits in accordance with 21 CFR 820, ISO 13485:2016, MDSAP, and/or EU MDR

Self-disciplined with strong time management skills

Strong organizational skills

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

Social Competencies

Excellent communication skills (written and verbal)

Must be able to work effectively in teams and be collaborative

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

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

Language(s) / Level English - Fluent Second language

IT skills 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.

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 guaranteeevery 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.