<p>Who we are</p> <p>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, through our core business brands - Advanced Bionics, Audiological Care, Phonak, Sennheiser (under license) and Unitron - we develop, manufacture and distribute solutions that push the limits of technology and redefine the future of our industry.</p> <p>Aurora, IL</p> <p>Senior Quality System Engineer</p> <p>We are looking for a Senior Quality System Engineer to lead and maintain key elements of our Quality Management System (QMS). This role ensures compliance with global medical device regulations, supports audits, and drives continuous improvement efforts across the business.</p> <p>Key Responsibilities:</p> <ul> <li>Maintain and improve our Quality Management System (QMS) in line with ISO 13485 and FDA requirements </li><li>Support internal and external audits (FDA, MDSAP, ISO, etc.) </li><li>Lead or support investigations for quality issues and ensure effective CAPA (Corrective and Preventive Actions) </li><li>Assist in developing and updating quality policies, SOPs, and training materials </li><li>Support global initiatives for QMS harmonization </li><li>Drive process improvements and ensure cross-functional alignment </li><li>Provide metrics and reports to track QMS performance </li></ul> <p>More About You:</p> <ul> <li>Bachelor's degree in Engineering or Life Sciences </li><li>5+ years of experience in Quality Assurance within the medical device industry </li><li>Strong knowledge of ISO 13485, 21 CFR 820, and global regulatory requirements </li><li>Experience supporting audits and managing CAPA </li><li>Skilled in process improvement and project management </li><li>Excellent communication and organizational skills </li></ul> <p>Nice to Have:</p> <ul> <li>Certified Lead Auditor </li><li>Experience with SAP, MasterControl, and QMS tools </li></ul> <p>Travel:</p> <p>Up to 5%</p> <p>A minimum of 200Mb/sec download and 10Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality at Sonova.</p> <p>A minimum of 200Mb/sec download and 10Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality at Sonova</p> <p>Don't meet all the criteria? If you're willing to go all in and learn we'd love to hear from you!</p> <p>We are looking forward to receiving your application via our online job application platform. For this position only direct applications will be considered. Sonova does not recruit via app, telegram, carrier pigeon or any other format that does not include speaking with an actual human. If you are offered a job without speaking with someone please contact</p> <p>What we offer:</p> <ul> <li> <p>Medical, dental and vision coverage*</p> </li><li> <p>Health Savings, Health Reimbursement, Flexible Spending/Dependent Care Accounts</p> </li><li> <p>TeleHealth options</p> </li><li> <p>401k plan with company match*</p> </li><li> <p>Company paid life/ad&d insurance</p> </li><li> <p>Additional supplemental life/ad&d coverage available</p> </li><li> <p>Company paid Short/Long-Term Disability coverage (STD/LTD)</p> </li><li> <p>STD LTD Buy-ups available</p> </li><li> <p>Accident/Hospital Indemnity coverage</p> </li><li> <p>Legal/ID Theft Assistance</p> </li><li> <p>PTO (or sick and vacation time), floating Diversity Day, & paid holidays*</p> </li><li> <p>Paid parental bonding leave</p> </li><li> <p>Employee Assistance Program (24/7 mental health support hotline, 5 company paid counseling sessions and more)</p> </li><li> <p>Robust Internal Career Growth opportunities</p> </li><li> <p>Tuition reimbursement</p> </li><li> <p>Hearing aid discount for employees and family</p> </li><li> <p>Internal social recognition platform</p> </li><li> <p>D&I focused: D&I council and employee resource groups</p> </li><li> <p>Plan rules/offerings dependent upon group Company/location.</p> </li></ul> <p>This role's pay range is between: $88,000 - $100,000 annually</p> <p>How we work:</p> <p>At Sonova, we prioritize the well-being of our employees and foster an inclusive environment that promotes engagement and collaboration. Our team-customized hybrid work model empowers teams to balance individual needs with business goals, offering flexibility and individualized time management. We recognize the importance of life outside of work and strive to create a supportive and motivating workplace where innovation thrives.</p> <p>Sonova is an equal opportunity employer.</p> <p>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.</p> <p>158695</p>