Sr Quality Engineer
1 month 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 Senior 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
- Work in an environment using a risk-based approach (ISO 14971).
- Lead equipment Verification & Validations (V&V) and development of plans and protocols (IQ/OQ/PQ).
- Work closely with the project management team and Regulatory Affairs 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.
- Develop product validation plans and support product validation testing.
- Support the Quality 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.
- 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.
- Bachelor's degree (Engineering, Science, or related field preferred) or commensurate offsetting experience in Quality Engineering.
- 5+ years hands-on experience in medical device quality engineering.
- Experience with FDA regulated products and ISO 13485 certified QMS.
- Experience with ISO 14971 risk management tools, design controls, and equipment/process validation (IQ/OQ/PQ).
- 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.
- 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 a plus.
- Experience in a medical device start-up environment is a plus.
- Experience in optics/opthalmics is a plus.
- Proficiency with Minitab, MS Outlook, MS Word, and MS Excel.
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