Principal Engineer, RoHS and Supplier Quality Assurance

Sonova AG•Santa Clarita, CA

25d•Onsite

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
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

Nice To Haves

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

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