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Sonova Group · 4 days ago

Principal Engineer, RoHS and Supplier Quality Assurance

Valencia (CA), United States

Full-time

Onsite

Senior Level, Lead/Staff

$126K/yr - $190K/yr

10+ years exp

Sonova Group is a leader in the medical device industry, and they are seeking a Principal Engineer to lead compliance efforts related to international substance regulations. This role involves ensuring that product materials meet global regulatory requirements and that suppliers adhere to stringent medical device standards.

Medical Device

H1B Sponsor Likely

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

Qualification

RoHS complianceREACH complianceISO 13485Quality EngineeringRoot cause analysisAgile PLMSAPCertified Quality EngineerLead Auditor 13485Materials scienceClass III medical devicesProject ManagementMinitabCADStatistical analysisJapanese problem-solving

Required

Bachelor's Degree in technical / scientific/engineering adjacent discipline

10+ years of progressive experience in Quality or Engineering in a regulated Industry

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

Preferred

Certified Quality Engineer, Advanced technical degree, or Certified Lead Auditor 13485 highly preferred

Experience in the Class III medical device sector is strongly preferred

Reach/RoHS or Materials science experience preferred

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

Company

Sonova Group

Glassdoor3.7

Around 25% of the world’s population is living with hearing loss.

Founded in 1947

Stäfa, CH

10001+ employees

http://www.sonova.com

H1B Sponsorship

Sonova Group has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (1)

2024 (3)

2023 (1)

2022 (3)

2020 (1)