Quality Engineer
2 months ago
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
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