Senior Engineer, Operations Quality

Valencia CA Onsite

Senior Engineer Operations Quality

The Senior Engineer Operations Quality is responsible for compliance to procedures and regulations for Manufacturing Controls of Implant and Externals Products and works within a multidisciplinary product development team to ensure the design intent of products is realized effectively and efficiently including compliance with 21CFR820 ISO13485 ISO 14971 MDSAP and MDR.

Responsibilities:

• Oversees all Manufacturing Quality Assurance activities across multiple projects to ensure alignment with strategic objectives and compliance with product specifications regulatory requirements and international standards.
• Collaborates with Receiving Inspection Quality Control Supplier Quality and Manufacturing/Operations to maintain efficient processes while supporting thirdparty audits and providing crossfunctional status reporting on risks issues and deliverables.
• Interprets and applies global medical manufacturing standards (ISO 13485 ISOCFR 820 MDSAP EUMDR) and leads requirements gathering with Engineering Marketing Clinical and Regulatory teams.
• Plans executes and documents testing activities including design transfer IQ/OQ/PQ and verification/validation of manufacturing processes equipment and tooling.
• Drives continuous improvement by recommending and implementing process enhancements supporting investigations (CAPA NCMR MRB) and conducting rootcause analyses for products systems and processes.
• Contributes to regulatory submissions delivers compliance training mentors junior team members and serves as the QA representative in crossfunctional teams GEMBA walks Kaizen events and general quality support activities.

More about you:

• Holds a bachelors degree in engineering (or equivalent experience); an advanced engineering degree or Certified Quality Engineer credential is preferred.
• Brings at least 5 years of Quality Engineering experience in Medical Device Manufacturing ideally with Class III Active Implantable Devices.
• Demonstrates strong interpersonal and leadership skills able to coach teams and collaborate across departments under pressure and tight timelines.
• Skilled in driving continuous improvement through consensus building root cause analysis Six Sigma and advanced statistical problem-solving.
• Proficient in quality practices specific to medical devices including regulatory standards such as ISOCFR 820 and MDSAP.
• Fluent in English; Spanish bilingualism is a plus.
• Experienced with Microsoft Office and engineering software; familiarity with Agile PLM SAP Minitab and CAD/solid modeling is preferred.

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

Dont meet all the criteria If youre willing to go allin and learn wed love to hear from you!

We are looking forward to receiving your application via our online job application platform. For this position only direct applications will be considered. Sonova does not recruit via app telegram carrier pigeon or any other format that does not include speaking with an actual human. If you are offered a job without speaking with someone please contact Sonova Human Resources

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 roles pay range is between: $95200/yr - $142800/yr. This role is also 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.