Principal Engineer, RoHS and Supplier Quality Assurance
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Job Location:
Valencia, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Valencia CA - Onsite
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 companys 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:
- Bachelors Degree in technical / scientific/engineering adjacent discipline.
- Certified Quality EngineerAdvanced technical degree o 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 orMaterials 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 orCAD / 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
Dont meet all the criteria If youre willing to go allin and learn wed love to hear from you!
We are looking forward to receiving your application via our online job application platform. For this position only direct applications will be considered. Sonova does not recruit via app telegram carrier pigeon or any other format that does not include speaking with an actual human. If you are offered a job without speaking with someone please contact Sonova Human Resources.
What we offer:
- 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.
This roles pay range is between: $126400/yr - $189600/yr compensation is based on skillset and location. This role is also bonus eligible.
How we work:
At Sonova we prioritize the well-being of our employees and foster an inclusive environment that promotes engagement and collaboration. Our team-customized hybrid work model empowers teams to balance individual needs with business goals offering flexibility and individualized time management. We recognize the importance of life outside of work and strive to create a supportive and motivating workplace where innovation thrives.
Required Experience:
Staff IC
Key Skills
- Test Cases
- Performance Testing
- Quality Assurance
- SOC
- Agile
- Debugging
- Jira
- Perl
- Software Testing
- Test Automation
- Scripting
- Selenium
About Company
Around 25% of the world’s population is living with hearing loss. At Sonova, we envision a world where everyone enjoys the delight of hearing and lives a life without limitations. From hearing aids to cochlear implants to wireless communication, we are committed to offering the most c ... View more
