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Senior Quality Engineer
Job in
Lewisville, Denton County, Texas, 75029, USA
Listed on 2026-02-16
Listing for:
Hoya
Full Time
position Listed on 2026-02-16
Job specializations:
-
Engineering
Quality Engineering, Biomedical Engineer -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
Join The HOYA Vision Care Team!
For over 60 years, HOYA Vision Care has been a passionate leader in optical technology innovation. As a manufacturer of high quality, high performing eyeglass lenses, we continuously aim to bring the best possible vision care solutions to eye care professionals.
We are currently hiring a Senior Quality Engineer in our Ramsey, MN location!
Salary Range: $120K+
What’s in it for you?- Health/Dental/Vision/Disability Insurance
- Tuition Reimbursement
- 401K plans
- PTO and Paid Holidays
- And more!
- Support the NA Quality Manager with QMS redevelopment and maintenance
- Collaborate with cross functional teams and other departments to provide quality leadership, guidance, training, and support in QMS Implementation/execution.
- Support equipment qualification and development of plans and protocols (IQ/OQ/PQ)
- Work closely with the project management team to ensure that our medical devices meet regulatory and quality requirements
- Conduct risk assessments and participate in failure mode and effects analysis (FMEA) activities
- Develop documentation (i.e. quality plans, procedures) to ensure compliance with applicable regulations
- Participate in the development of product validation plans and support product validation testing
- Perform internal QMS audits to ensure compliance with quality requirements
- Support the Quality Manager with external audits (i.e. ISO 9001, ISO 13485, FDA)
- Investigate and document non-compliances, identify root causes, and develop corrective and preventive actions
- 5+ years hands-on experience in medical device quality engineering
- Experience with QMS development is a plus
- Experience with FDA regulated products and ISO 13485 certified QMS
- Experience in product development including implementing appropriate controls
- Working knowledge of statistics is required, with Six Sigma Green Belt (or higher) certification being a plus
- Working knowledge of FDA regulations (21 CFR 820) and other relevant standards is strongly preferred
- Experience in a medical device start-up environment is strongly preferred
- ASQ certification as a Quality Engineer is a plus
- Experience in performing QMS audits is preferred, with ASQ certification as a Quality Auditor being a plus
- Experience in optics/opthalmics is a plus
- Proficiency with Minitab, MS Outlook, MS Word, and MS Excel
- Experience with ISO 14971 risk management is a plus
- Bachelor’s degree (Engineering, Science, or related field preferred) or commensurate offsetting experience in Quality Engineering
Position Requirements
10+ Years
work experience
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