Quality Engineer

HOYA and Seiko Driven by passion for innovation and development, Hoya Vision is constantly moving boundaries. By use of extensive research and cutting- edge technology we provide tailored optimized experiences - both for the eye care professional and the spectacle wearer.
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 Quality Engineer in Ramsey, MN
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:

• Work closely with the project management team to ensure that our medical devices meet regulatory and quality requirements
• Collaborate with cross functional teams and other departments to provide quality leadership, guidance and support in design control methodologies for medical device designs
• Conduct risk assessments and participate in design failure mode and effects analysis (DFMEA) 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
• Support the Quality and Metrology Manager with QMS maintenance and development
• 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:

• Bachelor's degree in Engineering, Science, or related field
• 2+ years hands-on experience in medical device Quality Engineering
• 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 performing QMS audits is preferred, with ASQ certification as a Quality Auditor being a plus
• Experience in a medical device start-up environment is a plus
• Experience with risk management tools, design controls, and process validation (IQ/OQ/PQ) is a plus
• Experience in optics/opthalmics is a plus
• Proficiency with Minitab, MS Outlook, MS Word, and MS Excel

At HOYA, our foundation is built upon a diverse and inclusive work environment. Together, our differences are key to maintaining an inclusive culture that supports and inspires employee's uniqueness. Our differences ignite our innovation and connects us to our diverse customers and communities we serve.
We're passionate about maintaining an inclusive work environment, not only because it's the right thing to do, it promotes and celebrates differences. We are also committed to providing equal opportunity to people of all races, ethnicities, religions, genders, sexual orientations, gender identifications, disabilities, ages, philosophies, and veteran statuses at all levels of the organization.
Hoya and Seiko Optical is committed to providing equal opportunity in all employment practices, including but not limited to selection, hiring, promotion, transfer and compensation to all qualified applicants and employees without regard to age, race, color, national origin, religion, gender, handicap or disability, or any other category protected by federal state or local law.

Disability insurance, Health insurance, Dental insurance, 401(k), Tuition reimbursement, Paid time off, Vision insurance