Senior Engineer, Operations Quality

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

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At Sonova, we envision a world where everyone can enjoy the delight of hearing. This vision inspires us and fuels our commitment to developing innovative solutions that improve hearing health and human connection - from personal audio devices and wireless communication systems to hearing aids and cochlear implants. We're dedicated to providing outstanding customer experiences through our global audiological care services, ensuring that everyone has the opportunity to engage fully with the world around them.

Guided by a culture of continuous improvement that fosters resilience and self-motivation, our team is united by a shared commitment to excellence and a deep sense of pride in our work, each of us playing a vital role in creating meaningful change,

Here you’ll find a diverse range of opportunities that span both consumer and medical solutions and the freedom to shape your career while making an impact on the lives of others. Join us in our mission to create a more connected world, where every voice is heard and every story matters.

Senior Engineer, Operations Quality

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Senior Engineer, Operations Quality

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
• 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
• Hearing aid discount for employees and family
• Internal social recognition platform

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 guaranteeevery 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.