Senior Engineer, Operations Quality

Sr. Engineer, Operations Quality

Valencia, CA - Onsite

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

CFR
820, ISO
13485, ISO 14971, MDSAP and MDR.

• 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.

• Bachelor’s degree in Engineering or Associate’s degree in Engineering with seven years of equivalent experience; advanced degree in Engineering, Certified Quality Engineer (CQE) certification, or other advanced technical degree is preferred.
• Minimum five years of Quality Engineering experience in medical device manufacturing, with experience supporting Class III Active Implantable Medical Devices considered highly desirable.
• 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, with bilingual Spanish skills and experience using Agile PLM, SAP, Minitab, CAD, and solid modeling applications considered a plus.

• Medical, dental and vision coverage*
• Health Savings, Health Reimbursement, Flexible Spending/Dependent Care Accounts
• Tele Health 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/ 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.

Sonova is an equal opportunity employer and guarantees equal treatment in regard to employment and opportunity for employment, regardless of a candidate’s ethnic or national origin, religion, sexual orientation or marital status, gender, genetic identity, age, disability or any other legally protected status.