Senior Engineer, Operations Quality

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

Senior Engineer, Operations Quality

Valencia, CA (On-Site)

Advanced Bionics is seeking an on-site Senior Engineer, Operations Quality to support compliance, manufacturing quality, and operational excellence for implant and external products. This role is responsible for ensuring Manufacturing Controls are compliant with procedures, regulatory requirements, internal standards, and international standards, including 21 CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR. This role partners closely with Manufacturing, Operations, Quality Control, Supplier Quality, Receiving Inspection, Engineering, Clinical, Regulatory, and cross-functional teams to help ensure products meet quality, regulatory, and performance expectations.

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

More about you:

• 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

Travel: Up to 10%

A minimum of 200Mb/sec download and 10Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality at Sonova

What we offer:

• Medical, dental and vision coverage*
• Health Savings, Health Reimbursement, Flexible Spending/Dependent Care Accounts
• TeleHealth options
• 401k plan with company match*
• Company paid life/ad&d insurance
  • Additional supplemental life/ad&d coverage available
• Company paid Short/Long-Term Disability coverage (STD/LTD)
  • STD LTD Buy-ups available
• Accident/Hospital Indemnity coverage
• Legal/ID Theft Assistance
• PTO (or sick and vacation time), floating Diversity Day, & paid holidays*
• Paid parental bonding leave
• Employee Assistance Program (24/7 mental health support hotline, 5 company paid counseling sessions and more)
• Robust Internal Career Growth opportunities
• Tuition reimbursement
• Hearing aid discount for employees and family
• Internal social recognition platform

*Plan rules/offerings dependent upon group Company/location

This role's pay range is between: $100,320 - $124,400 annually . This role is also commission eligible/bonus eligible.

How we work:

At Sonova, we prioritize the well-being of our employees and foster an inclusive environment that promotes engagement and collaboration. Our team-customized hybrid work model empowers teams to balance individual needs with business goals, offering flexibility and individualized time management. We recognize the importance of life outside of work and strive to create a supportive and motivating workplace where innovation thrives.

Sonova is an equal opportunity employer

We team up. We grow talent. We collaborate with people of diverse backgrounds to win with the best team in the market place. We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of a candidate's ethnic or national origin, religion, sexual orientation or marital status, gender, genetic identity, age, disability or any other legally protected status.