Sonova USA Inc.
Principal Engineer, RoHS and Supplier Quality Assurance
Sonova USA Inc., Santa Clarita, California, United States, 91382
Overview
Principal Engineer, RoHS and Supplier Quality Assurance – Valencia, CA – Hybrid Who we are: In a life without sound, our work provides meaning. As a leading provider of innovative hearing care solutions, we are a team on a mission to help people enjoy the delight of hearing. To enable a life without limitations, we develop, manufacture and distribute solutions that push the limits of technology and redefine the future of our industry. Sonova is an equal opportunity employer. Responsibilities
Lead and coordinate compliance efforts related to international substance regulations (e.g., REACH, RoHS) across the company's supplier base for materials and components used in Class III medical devices. Ensure product materials meet global regulatory requirements and that suppliers adhere to medical device standards such as 21 CFR 820, ISO 13485, ISO 14971, MDSAP, MDR, and relevant environmental policies. Serve as the strategic authority on global substance compliance, oversee supplier data acquisition, SVHC assessments, and compliance risk mitigation, and manage Material Declarations, Certificates of Compliance, and IMDS/BOMCheck submissions. Interpret emerging global regulations, conduct enterprise-level risk assessments, and translate technical requirements into business-aligned compliance strategies. Direct advanced supplier quality programs, audits, and remediation efforts in alignment with regulatory standards for Class III devices. Define supplier qualification frameworks, QA protocols, and cross-functional defect management to strengthen supplier partnerships. Represent the company as a subject matter expert in FDA/Notified Body inspections and industry forums; mentor teams and deliver compliance training. Champion digital quality tools, executive dashboards, and KPI reporting to drive transparency and continuous improvement in compliance performance. Other duties as assigned. More about you
Education Bachelor's Degree in a technical/scientific/engineering-adjacent discipline. Nice to Have Graduate degree Certified Quality Engineer Advanced technical degree Certified Lead Auditor 13485 Further Education Nice to Have Project Management competency Root cause analysis skills, including problem-solving approaches and statistical methods Work Experience 10+ years of progressive experience in Quality or Engineering in a regulated industry. Experience in the Class III medical device sector is strongly preferred Reach/RoHS experience; materials science experience Professional Competencies Strong understanding of REACH, RoHS, and other substance regulations (e.g., TSCA, Prop 65). Language(s)/ Skills English Nice to Have: Spanish or German IT Skills Microsoft Office/Engineering software Nice to Have: Agile PLM; SAP; Minitab; CAD/Solid Modeling knowledge Work environment and compensation
A minimum of 200 Mb/sec download and 10 Mb/sec upload speed internet connectivity is required for remote/hybrid employees. Salary: The pay range for this role is $126,400/yr – $189,600/yr, compensation based on skillset and location. This role is bonus eligible. What we offer
Medical, dental and vision coverage Health Savings, Health Reimbursement, Flexible Spending Accounts TeleHealth options 401k with company match Company-paid life/AD&D insurance; optional supplemental coverage Company-paid STD/LTD; Buy-ups available Accident/Hospital Indemnity coverage Legal/ID Theft Assistance PTO, floating Diversity Day, paid holidays Paid parental bonding leave Employee Assistance Program (24/7 mental health support) Internal career growth opportunities Tuition reimbursement Hearing aid discount for employees and family Internal social recognition platform *Plan rules/offerings dependent upon group/location. How we work We prioritize well-being, foster an inclusive environment, and support a team-customized hybrid work model that balances individual needs with business goals. Sonova is an equal opportunity employer.
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Principal Engineer, RoHS and Supplier Quality Assurance – Valencia, CA – Hybrid Who we are: In a life without sound, our work provides meaning. As a leading provider of innovative hearing care solutions, we are a team on a mission to help people enjoy the delight of hearing. To enable a life without limitations, we develop, manufacture and distribute solutions that push the limits of technology and redefine the future of our industry. Sonova is an equal opportunity employer. Responsibilities
Lead and coordinate compliance efforts related to international substance regulations (e.g., REACH, RoHS) across the company's supplier base for materials and components used in Class III medical devices. Ensure product materials meet global regulatory requirements and that suppliers adhere to medical device standards such as 21 CFR 820, ISO 13485, ISO 14971, MDSAP, MDR, and relevant environmental policies. Serve as the strategic authority on global substance compliance, oversee supplier data acquisition, SVHC assessments, and compliance risk mitigation, and manage Material Declarations, Certificates of Compliance, and IMDS/BOMCheck submissions. Interpret emerging global regulations, conduct enterprise-level risk assessments, and translate technical requirements into business-aligned compliance strategies. Direct advanced supplier quality programs, audits, and remediation efforts in alignment with regulatory standards for Class III devices. Define supplier qualification frameworks, QA protocols, and cross-functional defect management to strengthen supplier partnerships. Represent the company as a subject matter expert in FDA/Notified Body inspections and industry forums; mentor teams and deliver compliance training. Champion digital quality tools, executive dashboards, and KPI reporting to drive transparency and continuous improvement in compliance performance. Other duties as assigned. More about you
Education Bachelor's Degree in a technical/scientific/engineering-adjacent discipline. Nice to Have Graduate degree Certified Quality Engineer Advanced technical degree Certified Lead Auditor 13485 Further Education Nice to Have Project Management competency Root cause analysis skills, including problem-solving approaches and statistical methods Work Experience 10+ years of progressive experience in Quality or Engineering in a regulated industry. Experience in the Class III medical device sector is strongly preferred Reach/RoHS experience; materials science experience Professional Competencies Strong understanding of REACH, RoHS, and other substance regulations (e.g., TSCA, Prop 65). Language(s)/ Skills English Nice to Have: Spanish or German IT Skills Microsoft Office/Engineering software Nice to Have: Agile PLM; SAP; Minitab; CAD/Solid Modeling knowledge Work environment and compensation
A minimum of 200 Mb/sec download and 10 Mb/sec upload speed internet connectivity is required for remote/hybrid employees. Salary: The pay range for this role is $126,400/yr – $189,600/yr, compensation based on skillset and location. This role is bonus eligible. What we offer
Medical, dental and vision coverage Health Savings, Health Reimbursement, Flexible Spending Accounts TeleHealth options 401k with company match Company-paid life/AD&D insurance; optional supplemental coverage Company-paid STD/LTD; Buy-ups available Accident/Hospital Indemnity coverage Legal/ID Theft Assistance PTO, floating Diversity Day, paid holidays Paid parental bonding leave Employee Assistance Program (24/7 mental health support) Internal career growth opportunities Tuition reimbursement Hearing aid discount for employees and family Internal social recognition platform *Plan rules/offerings dependent upon group/location. How we work We prioritize well-being, foster an inclusive environment, and support a team-customized hybrid work model that balances individual needs with business goals. Sonova is an equal opportunity employer.
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