Sr Quality Engineer

Job Description 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 What you'll do: 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. Qualifications: 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.