Senior Engineer, Operations Quality

Sonova AG•Santa Clarita, CA

6d•$100,320 - $150,480•Onsite

About The Position

The Senior Engineer, Operations Quality is responsible for compliance to procedures and regulations for Manufacturing Controls of Implant and Externals Products and works within a multidisciplinary product development team to ensure the design intent of products is realized effectively and efficiently, including compliance with 21CFR820, ISO13485, ISO 14971, MDSAP and MDR.

Requirements

Bachelor’s degree in Engineering or Associate’s degree in Engineering with seven years of equivalent experience
Minimum five years of Quality Engineering experience in medical device manufacturing
Proven ability to work effectively with all levels of management and lead, coach, or influence engineering teams without formal authority while fostering collaboration and consensus-building.
Strong interpersonal and communication skills with the ability to work under pressure, meet project timelines, and collaborate successfully across departments and organizational levels.
Demonstrated expertise in medical device quality practices, continuous improvement initiatives, professionalism, and effective stakeholder engagement within a regulated manufacturing environment.
Strong competencies in project management, root cause investigation and analysis, process improvement methodologies, Six Sigma techniques, and advanced statistical analysis for problem-solving and decision-making.
Proficiency in English, Microsoft Office, and engineering software

Nice To Haves

advanced degree in Engineering
Certified Quality Engineer (CQE) certification, or other advanced technical degree is preferred
experience supporting Class III Active Implantable Medical Devices considered highly desirable
bilingual Spanish skills
experience using Agile PLM, SAP, Minitab, CAD, and solid modeling applications

Responsibilities

Lead Manufacturing Quality Assurance activities across multiple projects, ensuring alignment with strategic objectives and supporting compliant, efficient manufacturing operations.
Partner with Receiving Inspection, Quality Control, Supplier Quality, Manufacturing, and Operations teams to maintain streamlined production processes, support audits, and communicate project status, risks, dependencies, and deliverables to management and stakeholders.
Provide subject matter expertise on the implementation, interpretation, and compliance of medical device regulations and standards, including ISO 13485, ISO 14971, 21 CFR 820, MDSAP, EU MDR, and other applicable international requirements.
Collaborate with Engineering, Marketing, Clinical, and Regulatory teams to define requirements and ensure products consistently meet specifications, regulatory expectations, and quality standards.
Plan, execute, and report on manufacturing validation and verification activities, including design transfer, IQ, OQ, PQ, process validation, tooling qualification, and related testing programs.
Drive continuous improvement initiatives by recommending and implementing process enhancements, supporting investigations, nonconformances, CAPAs, NCMRs, MRBs, change controls, and root cause analyses for products, systems, and processes.
Support regulatory submissions, deliver compliance and quality training, mentor and guide team members, and serve as the Quality Assurance representative on cross-functional teams, GEMBA walks, and Manufacturing Kaizen events.

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