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 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 / ophthalmic is a plus
• Proficiency with Minitab, MS Outlook, MS Word, and MS Excel
30+ days ago