Senior Engineer, Quality & Compliance - Medical Devices

Sonova Group; California (MO); Hybrid; 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

STD/LTD coverage

PTO / Diversity Day

Job summary

Sonova is seeking a Senior Engineer, Operations Quality on-site to support compliance, manufacturing quality, and operational excellence for implant and external products. You will ensure Manufacturing Controls meet procedures, regulatory requirements, and standards such as 21 CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR.

You will collaborate with Manufacturing, Operations, Quality Control, Supplier Quality, Receiving Inspection, Engineering, Clinical, Regulatory, and cross-functional teams to

Qualifications

• Bachelor’s degree in Engineering required, or Associate’s with 7 years of equivalent work experience.
• Minimum of 5 years of Quality Engineering experience in medical device manufacturing required.
• 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.

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

Project management

Education

Bachelor’s degree in Engineering

Associate’s degree in Engineering with 7 years of experience

Tools

Agile PLM

SAP

Minitab

CAD / solid modeling

Job description

Sonova is seeking a Senior Engineer, Operations Quality on-site to support compliance, manufacturing quality, and operational excellence for implant and external products. You will ensure Manufacturing Controls meet procedures, regulatory requirements, and standards such as 21 CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR.

You will collaborate with Manufacturing, Operations, Quality Control, Supplier Quality, Receiving Inspection, Engineering, Clinical, Regulatory, and cross-functional teams to