Senior Engineer, Operations Quality - Medical Devices

Sonova Group; Santa Clarita (CA); 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

Tuition reimbursement

Job summary

Advanced Bionics, part of the Sonova Group, seeks a Senior Engineer, Operations Quality on-site in Valencia, CA. You will ensure compliance with 21 CFR 820, ISO 13485, ISO 14971, MDSAP and MDR, leading Manufacturing Controls across multiple programs to support high-quality implants and external devices.

You will partner across Manufacturing, Operations, Quality, and Regulatory teams to drive CAPA, root-cause analysis, and robust quality improvements in a fast-paced medical device environment.

Qualifications

• Bachelor’s degree in Engineering or an Associate’s degree in Engineering with 7 years of equivalent work experience.
• Minimum 5 years of Quality Engineering experience in medical device manufacturing.
• Class III active implantable medical device experience preferred.
• Strong knowledge of quality practices, regulatory requirements, and manufacturing controls in a medical device environment.
• Experience with CAPA, root cause analysis, and cross-functional collaboration.

Responsibilities

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

Skills

Quality Engineering

Regulatory requirements

Project management

Root cause analysis

Six Sigma

Statistical analysis

Agile PLM

SAP

Minitab

CAD / Solid modeling

Education

Bachelor's degree in Engineering

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

Tools

Agile PLM

SAP

Minitab

CAD / Solid modeling

Job description

Advanced Bionics, part of the Sonova Group, seeks a Senior Engineer, Operations Quality on-site in Valencia, CA. You will ensure compliance with 21 CFR 820, ISO 13485, ISO 14971, MDSAP and MDR, leading Manufacturing Controls across multiple programs to support high-quality implants and external devices.

You will partner across Manufacturing, Operations, Quality, and Regulatory teams to drive CAPA, root-cause analysis, and robust quality improvements in a fast-paced medical device environment.