Principal Engineer, RoHS and Supplier Quality Assurance
Listed on 2025-12-20
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Engineering
Quality Engineering
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You enjoy creating and innovating. You never stop striving for better. You take responsibility and you get results. You love being part of a team. Above all, you want your work to matter:
Welcome to our world! At Sonova we create sense by bringing sound to life. Our innovative hearing care solutions help millions of people enjoy life’s unforgettable moments.
We offer exceptional career opportunities through market-leading brands from consumer to medical, products and services that keep pushing hearing care forward, and a culture where you can quickly belong and perform at your best.
If you want the freedom to explore, opportunities to grow, and make positive change on people lives through your work, this is the place for you.
Join Sonova. Create sense.
Principal Engineer, RoHS and Supplier Quality Assurance159217
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, 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.
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
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.
- 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
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.
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