Sonova

1 month ago

Senior Engineer, Operations Quality

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 4 hours agoStatus: Live

Job Summary

Senior Engineer, Operations Quality leads Manufacturing Quality Assurance across multiple projects, ensuring compliance with medical device regulations and quality standards (21 CFR 820, ISO 13485, MDR) while collaborating with Regulatory, Engineering, and Manufacturing teams to ensure design transfer, verification, and continuous improvement of production processes.

Location: United States

Workplace: Onsite

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Key Responsibilities

•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.

Travel: Low travel

Pay and Benefits

Salary: USD 100,320 - 150,480 annually

Key Requirements

•Bachelor’s degree in Engineering or Associate’s degree in Engineering; seven years of equivalent experience preferred
•Minimum five years of Quality Engineering experience in medical device manufacturing, with experience on Class III active implantable devices preferred
•Proven ability to lead and influence engineering teams, collaborate across departments, and meet project timelines
•Strong knowledge of medical device regulations and standards (ISO 13485, ISO 14971, 21 CFR 820, MDSAP, EU MDR) and quality systems
•Proficiency with engineering software (Agile PLM, SAP, Minitab, CAD) and data-driven problem-solving

Experience:5+ yearsMedical devicesQuality engineeringRegulated manufacturing

Education:Bachelor's

Skills:CommunicationProblem-solvingLeadership

Certifications:CQE

Tech Stack:MinitabAgile PLMSAPCAD

Company Brief

Sonova

Designs, manufactures, and distributes hearing care solutions including hearing aids, cochlear implant accessories, and wireless communication devices, serving audiologists and consumers worldwide through clinics, retail networks, and distribution partners.

Industry: Medical Devices

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: Stäfa, Switzerland

Founded: 1947

Website

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Sonova

1 month ago

Senior Engineer, Operations Quality

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 4 hours agoStatus: Live

Job Summary

Location: United States

Workplace: Onsite

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Key Responsibilities

•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.

Travel: Low travel

Pay and Benefits

Salary: USD 100,320 - 150,480 annually

Key Requirements

•Bachelor’s degree in Engineering or Associate’s degree in Engineering; seven years of equivalent experience preferred
•Minimum five years of Quality Engineering experience in medical device manufacturing, with experience on Class III active implantable devices preferred
•Proven ability to lead and influence engineering teams, collaborate across departments, and meet project timelines
•Strong knowledge of medical device regulations and standards (ISO 13485, ISO 14971, 21 CFR 820, MDSAP, EU MDR) and quality systems
•Proficiency with engineering software (Agile PLM, SAP, Minitab, CAD) and data-driven problem-solving

Experience:5+ yearsMedical devicesQuality engineeringRegulated manufacturing

Education:Bachelor's

Skills:CommunicationProblem-solvingLeadership

Certifications:CQE

Tech Stack:MinitabAgile PLMSAPCAD

Company Brief

Sonova

Industry: Medical Devices

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: Stäfa, Switzerland

Founded: 1947

Website