
Principal Engineer, RoHS, Supplier Quality Assurance
Sonova Group
full-time
Posted on:
Location Type: Office
Location: Valencia • California • 🇺🇸 United States
Visit company websiteSalary
💰 $126,400 - $189,600 per year
Job Level
Lead
About the role
- 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.
Requirements
- Bachelor’s Degree in technical / scientific/engineering adjacent discipline.
- Certified Quality Engineer, Advanced technical degree, or Certified Lead Auditor 13485 highly preferred
- 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 or Materials science experience preferred
- Strong understanding of REACH, RoHS, and other substance regulations (e.g., TSCA, Prop 65).
- 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
- Agile PLM; SAP; Minitab or 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
Benefits
- 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
substance compliancerisk assessmentsupplier quality programsquality assurance protocolsroot cause assessmentstatistical analysisproject managementadvanced statistical analysisblack belt techniquesgreen belt techniques
Soft skills
leadershipmentoringcommunicationstrategic thinkingcross-functional collaborationproblem-solvingcontinuous improvementtraining deliverytranslating technical requirementsdefect management
Certifications
Bachelor’s DegreeCertified Quality EngineerCertified Lead Auditor 13485Advanced technical degree