Senior Engineer, Quality & Manufacturing—Medical Devices

Sonova USA, Inc.; California; On-site; USD 100,000 - 124,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

401k with company match

Life/AD&D insurance

Paid holidays

PTO and holidays

Tuition reimbursement

Job summary

Sonova USA, Inc. in Valencia, CA is seeking a Senior Engineer, Operations Quality on-site to lead manufacturing quality activities and ensure conformity with 21 CFR 820, ISO 13485, ISO 14971, MDSAP and EU MDR.

You will collaborate with cross-functional teams to drive CAPA, design transfers, and process validation. The role requires 5+ years in medical device quality engineering, with preference for Class III implantable device experience and strong regulatory knowledge.

Qualifications

• Bachelor's degree in Engineering required, or Associate's degree in Engineering with 7 years of equivalent work experience
• Minimum of 5 years of Quality Engineering experience in medical device manufacturing required
• Class III active implantable medical device experience preferred
• Strong knowledge of quality practices, regulatory requirements, and manufacturing controls in a medical device environment
• Ability to coach, mentor, and lead engineers without formal authority
• Strong communication, professionalism, collaboration, and cross-functional partnership skills
• Experience with project management, root cause analysis, process improvement, Six Sigma techniques, or advanced statistical analysis preferred
• Microsoft Office and engineering software experience required; Agile PLM, SAP, Minitab, and CAD or solid modeling experience preferred

Responsibilities

• Manage Manufacturing Quality Assurance activities for multiple related projects to ensure alignment with strategic objectives
• Partner with Receiving Inspection, Quality Control, Supplier Quality, Manufacturing, and Operations to support a streamlined manufacturing process
• Support third-party audits related to manufacturing processes, procedures, and policies
• Provide status reporting on manufacturing process deliverables, dependencies, risks, and issues
• Provide expertise on international standards including ISO 13485, ISO 14971, 21 CFR 820, MDSAP, and EU MDR
• Support design transfer, IQ, OQ, PQ, verification, validation, tooling, and manufacturing process testing activities
• Participate in investigations and dispositions related to nonconformances, CAPA, NCMR, MRB, product changes, and root cause analysis

Skills

Quality engineering

Regulatory compliance

Cross-functional collaboration

Root cause analysis

Education

Bachelor's degree in Engineering

Associate's degree in Engineering

Tools

Agile PLM

SAP

Minitab

CAD/Solid modeling

Job description

Sonova USA, Inc. in Valencia, CA is seeking a Senior Engineer, Operations Quality on-site to lead manufacturing quality activities and ensure conformity with 21 CFR 820, ISO 13485, ISO 14971, MDSAP and EU MDR.

You will collaborate with cross-functional teams to drive CAPA, design transfers, and process validation. The role requires 5+ years in medical device quality engineering, with preference for Class III implantable device experience and strong regulatory knowledge.