Valencia (CA), United States
Sr. Internal Auditor
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:
Lead the Advanced Bionics Global Auditing Program by applying working knowledge in the application of concepts, principles, and technical capabilities to perform varied tasks. This includes coordinating and/or executing audits (Internal and External) in accordance with established auditing procedures. Generate audit reports and findings, perform follow-up on corrective actions, and administrative tasks.
• Be responsible for the oversight and implementation of the Global Auditing Program, including maintaining an audit schedule, conducting audits, and identifying nonconformances
• Demonstrate comprehensive knowledge of auditing techniques and applicable regulatory requirements
• Prepare for audits by researching materials, standards, policies and procedures to formulate a plan of action
• Communicate before, during, and after audits regarding standards and regulatory requirements, audit scope, anticipated interview times, observations, etc.
• Ensure audit findings are factual, relevant, accurate, and are value added to the company’s quality system
• Identify opportunities for continuous improvement and drive implementation within the Global Auditing Program
• Identify possible solutions to a variety of problems and take actions to resolve
• Conduct root cause analysis and support finding owners as needed
• Create audit reports and all associated documents as required
• Maintain audit database and general administration of quality records within the Global Auditing Program
• Perform trending and analysis based on audit observations and present to senior management as part of management review
• Ensure timely closure of audit findings and manage responses to findings and/or observations from external audits
• Conduct annual assessments of the QMS by reviewing the outputs of the various feeder systems (e.g. internal and external audits, CAPAs, etc.) and propose 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
What you’ll bring:
Education:
HS diploma, or equivalent (Required)
Bachelor’s Degree (Required)
M.S. in Engineering, Science or equivalent (Preferred)
5+ 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 (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.