Principal Engineer, RoHS and Supplier Quality Assurance

Sonova USA • Santa Clarita, CA

130d • $126,400 - $189,600 • Hybrid

About The Position

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.

Requirements

• 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).
• English language proficiency.

Nice To Haves

• Graduate Degree.
• Certified Quality Engineer.
• Advanced technical degree.
• Certified Lead Auditor 13485.
• Experience in the Class III medical device sector is strongly preferred.
• Reach/RoHS experience.
• Materials science experience.
• 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.
• Spanish or German language proficiency.
• Agile PLM; SAP; Minitab; CAD / solid modeling knowledge, abilities, and experience.

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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Merchant Wholesalers, Nondurable Goods
• Education Level: Bachelor's degree