Sonova
Principal Engineer, RoHS and Supplier Quality Assurance
Sonova, California, Missouri, United States, 65018
Overview
Valencia, CA - Hybrid Principal Engineer, RoHS and Supplier Quality Assurance The purpose of this role is to lead and coordinate compliance efforts related to international substance regulations, including REACH and RoHS, across the company’s supplier base for materials and components used in Class III medical devices. This position ensures that product materials meet global regulatory requirements and that suppliers consistently adhere to stringent medical device standards such as 21 CFR 820, ISO 13485, ISO 14971, MDSAP, MDR, and relevant international environmental policies. Responsibilities
Serve as the strategic authority on global substance compliance (REACH, RoHS, etc.), ensuring integration across product lifecycle and supply chain. Lead supplier data acquisition, SVHC assessments, and compliance risk mitigation, while overseeing 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 ISO 13485, FDA QSR, MDR, and MDSAP standards for Class III medical devices. Define supplier qualification frameworks, quality assurance protocols, and cross-functional defect management processes to strengthen long-term supplier partnerships. Represent the company as subject matter expert in FDA/Notified Body inspections and industry forums, while mentoring teams and delivering compliance training. Champion digital quality tools, executive dashboards, and KPI reporting to drive transparency, system integration, and continuous improvement in compliance performance. Other duties as assigned. More about you
Education Bachelor’s Degree in technical / scientific/engineering adjacent discipline. Nice to Have Graduate Degree Further Education Nice to Have Certified Quality Engineer Advanced technical degree Certified Lead Auditor 13485 Work Experience
10+ years of progressive experience in Quality or Engineering in a regulated Industry. Nice to Have 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). Nice to Have Project Management competency Root cause assessment / analysis skills including knowledge of Japanese problem-solving practices, black/green belt techniques, advanced statistical analysis skills related to problem solving/analysis 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, abilities, and experience. A minimum of 200Mb/sec download and 10Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality at Sonova Don't meet all the criteria? If you’re willing to go allin and learn we'd love to hear from you! 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 Sonova Human Resources. What we offer
Medical, dental and vision coverage* Health Savings, Health Reimbursement, Flexible Spending/Dependent Care Accounts TeleHealth options 401k plan with company match* Company paid life/ad&d insurance
Additional supplemental life/ad&d coverage available
Company paid Short/Long-Term Disability coverage (STD/LTD)
STD LTD Buy-ups available
Accident/Hospital Indemnity coverage Legal/ID Theft Assistance PTO (or sick and vacation time), floating Diversity Day, & paid holidays* Paid parental bonding leave Employee Assistance Program (24/7 mental health support hotline, 5 company paid counseling sessions and more) Robust Internal Career Growth opportunities Tuition reimbursement Hearing aid discount for employees and family Internal social recognition platform *Plan rules/offerings dependent upon group Company/location. This role's pay range is between: $126,400/yr - $189,600/yr , compensation is based on skillset and location. This role is also bonus eligible. How we work
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.
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Valencia, CA - Hybrid Principal Engineer, RoHS and Supplier Quality Assurance The purpose of this role is to lead and coordinate compliance efforts related to international substance regulations, including REACH and RoHS, across the company’s supplier base for materials and components used in Class III medical devices. This position ensures that product materials meet global regulatory requirements and that suppliers consistently adhere to stringent medical device standards such as 21 CFR 820, ISO 13485, ISO 14971, MDSAP, MDR, and relevant international environmental policies. Responsibilities
Serve as the strategic authority on global substance compliance (REACH, RoHS, etc.), ensuring integration across product lifecycle and supply chain. Lead supplier data acquisition, SVHC assessments, and compliance risk mitigation, while overseeing 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 ISO 13485, FDA QSR, MDR, and MDSAP standards for Class III medical devices. Define supplier qualification frameworks, quality assurance protocols, and cross-functional defect management processes to strengthen long-term supplier partnerships. Represent the company as subject matter expert in FDA/Notified Body inspections and industry forums, while mentoring teams and delivering compliance training. Champion digital quality tools, executive dashboards, and KPI reporting to drive transparency, system integration, and continuous improvement in compliance performance. Other duties as assigned. More about you
Education Bachelor’s Degree in technical / scientific/engineering adjacent discipline. Nice to Have Graduate Degree Further Education Nice to Have Certified Quality Engineer Advanced technical degree Certified Lead Auditor 13485 Work Experience
10+ years of progressive experience in Quality or Engineering in a regulated Industry. Nice to Have 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). Nice to Have Project Management competency Root cause assessment / analysis skills including knowledge of Japanese problem-solving practices, black/green belt techniques, advanced statistical analysis skills related to problem solving/analysis 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, abilities, and experience. A minimum of 200Mb/sec download and 10Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality at Sonova Don't meet all the criteria? If you’re willing to go allin and learn we'd love to hear from you! 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 Sonova Human Resources. What we offer
Medical, dental and vision coverage* Health Savings, Health Reimbursement, Flexible Spending/Dependent Care Accounts TeleHealth options 401k plan with company match* Company paid life/ad&d insurance
Additional supplemental life/ad&d coverage available
Company paid Short/Long-Term Disability coverage (STD/LTD)
STD LTD Buy-ups available
Accident/Hospital Indemnity coverage Legal/ID Theft Assistance PTO (or sick and vacation time), floating Diversity Day, & paid holidays* Paid parental bonding leave Employee Assistance Program (24/7 mental health support hotline, 5 company paid counseling sessions and more) Robust Internal Career Growth opportunities Tuition reimbursement Hearing aid discount for employees and family Internal social recognition platform *Plan rules/offerings dependent upon group Company/location. This role's pay range is between: $126,400/yr - $189,600/yr , compensation is based on skillset and location. This role is also bonus eligible. How we work
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.
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