Senior Engineer - Medical Device Quality & Compliance

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

Benefits offered by this job

Medical, dental and vision coverage

401k plan with company match

PTO and paid holidays

Hearing aid discount for employees and

Job summary

Sonova USA Inc. in Valencia, CA is seeking an on-site Senior Engineer, Operations Quality to ensure manufacturing quality and regulatory compliance for implant and external products.

You’ll partner with Manufacturing, Quality Control, and Regulatory teams to drive quality, regulatory, and performance outcomes. The role requires a Bachelor’s degree in Engineering or equivalent with 5+ years in medical device quality, including knowledge of ISO 13485, 21 CFR 820, and MDSAP.

Qualifications

• Bachelor's degree in Engineering or equivalent experience with 7 years in quality engineering.
• 5+ years of Quality Engineering in medical device manufacturing.
• Class III implantable device experience preferred.
• Strong knowledge of regulatory requirements and manufacturing controls.

Responsibilities

• Manage Manufacturing Quality Assurance activities for multiple 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 knowledge

Cross-functional collaboration

Project management

Root cause analysis

Education

Bachelor's degree in Engineering

Associate's degree in Engineering with 7 years of equivalent work experience

Tools

Agile PLM

SAP

Minitab

CAD or Solid Modeling

Job description

Sonova USA Inc. in Valencia, CA is seeking an on-site Senior Engineer, Operations Quality to ensure manufacturing quality and regulatory compliance for implant and external products.

You’ll partner with Manufacturing, Quality Control, and Regulatory teams to drive quality, regulatory, and performance outcomes. The role requires a Bachelor’s degree in Engineering or equivalent with 5+ years in medical device quality, including knowledge of ISO 13485, 21 CFR 820, and MDSAP.