Senior Quality Engineer

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!

 What you’ll do:

• 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

 Qualifications:

• 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