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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

Change Control Analyst

 

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.

 

The Change Control Analyst position is responsible for timely processing of complete and accurate Change Orders in the Oracle Agile PLM (Product Lifecycle Management) system. The Analyst will ensure changes comply with company procedure and regulatory requirements. Essential duties performed will satisfactorily support other Document Control Department functions.  

 

What you’ll do:

 

Process Engineering and Manufacturer Change Orders using Oracle Agile PLM (Product Lifecycle Management) as a component of the Quality Management System

Process Project ECOs to completion including collaboration with R&D on change management for development projects

Ensure all change elements are identified, accurate, compliant and assembled for review and approval

Coordinate and assign documentation approvals

Fulfill requests for change control data, reports and information

Fulfill Regulatory Affairs submission requests for documentation

Activate, Inactivate and maintain user accounts in PLM

Train department personnel on Document Control systems, practice and procedure

Distribute workload among Change Analysts

Filing, data entry, traveler and document control stamping and distribution

Create and distribute daily release reports

Conduct ECO Creator Training for Advanced Bionics employees

Perform SolidWorks CAD drawing load verification and drafting

Process Camstar ECOs through completion using PLM, Camstar, & ERP systems

Execute data verification in the ERP system

Create, proof and release product and process labeling

Perform Document Control functions in Back Room during external audit

Prepare agenda for Change Management Review Board meetings

Support the Record Retention department with Device History Record maintenance and archiving

 

 

What you bring to the team:

 

Document Control experience

Proficiency with Oracle Agile PLM or equivalent system

Knowledge of Good Documentation Practices (GDP)

Basic knowledge of FDA regulated industry documentation procedures

Basic knowledge of Manufacturing Execution Systems (MES)

Basic knowledge of ERP systems

 

Excellent written, verbal, and interpersonal communication skills

Interact effectively with all levels of employees

Proficiency with Microsoft Office and Adobe Acrobat applications

Manage work load effectively and work on multiple tasks simultaneously

Work independently with good time management skills

Make sound decisions on a daily basis

Understands technical information content and context used by Manufacturing including Assembly Procedures, Work Instructions, Travelers

Understands technical information content and context used by Engineering including drawings, specifications, reports

Collaborate effectively with R&D on proposed changes

Understands Sales, Marketing and Advertising content and context for processing changes

Confidently interact with cross functional department personnel

Prioritize work load effectively to meet departmental and organizational goals

 

 

 

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.