Senior Engineer, Operations Quality

Who we are

In a life without sound, our work provides meaning. As a leading provider of innovative hearing care solutions, we are not just a company that makes products: we are a team on a mission to help people enjoy the delight of hearing. To enable a life without limitations, through our core business brands – Advanced Bionics, Audiological Care, Phonak, Sennheiser (under license) and Unitron – we develop, manufacture and distribute solutions that push the limits of technology and redefine the future of our industry.

Senior Engineer, Operations Quality (Onsite)

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:

• Manages all Manufacturing Quality Assurance aspects of multiple related projects to ensure the overall program is aligned to and directly supports the achievement of strategic objectives
• Partnering with Receiving inspection, Quality control, supplier quality, and Manufacturing/ Operations to ensure a streamlined manufacturing process is maintained
• Support 3rd party audits regarding manufacturing processes and policies
• Provides status reporting regarding manufacturing processes deliverable, dependencies, risks and issues, communicating across teams and to direct management
• Provides expertise to the manufacturing and design team on the implementation of international standards (ISO 14971, ISO 13485, particular standards, etc.) as they relate to manufactured product.
• Identification and interpretation of recognized standards for medical manufacturing (e.g. ISO 13485, 21 CFR 820, MDSAP, EUMDR etc.)
• Requirements discovery as solicited from Engineering, Marketing, Clinical, and Regulatory stakeholders
• Ensure product meets or exceeds product specifications, regulatory requirements, and international standards
• Responsible for various testing planning, execution and reporting, including design transfer, IQ, OQ, PQ. Verification and Validation of manufacturing processes and tooling etc.
• Recommends process improvements to management and executes to ensure consistent implementation of internal requirements and external regulations and standards.
• Participates / Supports investigations and dispositions of product, non- conformances and changes, CAPA, NCMR, MRB
• Supports/ Reviews root cause analysis/assessments of products, systems, and processes.
• As needed, prepares documentation for and support regulatory submissions (USA, EU, International)
• Creates and/or delivers training on compliance of medical devices per international standards
• Mentor, train or otherwise provide guidance to newer or less experienced team members, leveraging product skills and experience
• QA representative on cross functional teams, GEMBA walks, and/ or Manufacturing Kaizen Events
• Provides general quality support.
• Other duties as assigned.

Travelling Requirement: up to 10%

More about you:

Education

• Bachelor’s degree in engineering or associate’s degree in engineering and 7 years of equivalent work experience

Nice to Have

• Advanced degree in engineering

Further Education

Nice to Have

• Certified Quality Engineer Advanced technical degree

Work Experience

• Minimum of 5 years of previous Quality Engineering in Medical Device Manufacturing.

Nice to Have

• Minimum of 5 years of previous Quality Engineering in Medical Device Manufacturing for Class III Active Implantable Devices

Personal Competencies

• Must be able to work with all levels of management and ability to coach/lead a team of engineers without formal authority.

Social Competencies

• Ability to work under pressure and meet project timelines across departments

Leadership Competencies

• Ability to drive Continuous Improvement through collaboration and consensus building.

Professional Competencies

• Must be able to work with all levels of management and peers.
• Ability to maintain professionalism among peers and communicate effectively will all levels of the organization.
• Exhibits strong and comprehensive skill set related to quality practices in a medical device environment.

Nice to Have

• Project Management competency
• Root cause assessment / analysis skills including knowledge of process improvement problem-solving practices, Six Sigma techniques, advanced statistical analysis skills related to problem solving/analysis

Language(s)/ Level

• English/ Fluent

Nice to Have

• Spanish

IT Skills

• Microsoft Office/Engineering Software

Nice to Have

• Agile PLM; SAP; Minitab.
• CAD / solid modeling knowledge abilities and experience

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

Don't meet all the criteria?  If you’re willing to go all in and learn we'd love to hear from you! 

 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
• D&I focused: D&I council and employee resource groups

*Plan rules/offerings dependent upon group Company/location.

This role's pay range is between $94,400/yr - $141,600/yr (based on location). 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.