Hoya Vision Care · 12 hours ago
Senior Quality Engineer
Ramsey, MN
Full-time
Onsite
Senior Level
5+ years expHoya Vision Care is a leader in optical technology innovation, manufacturing high-quality eyeglass lenses. They are seeking a Senior Quality Engineer to support QMS redevelopment, collaborate with cross-functional teams, and ensure compliance with regulatory and quality requirements for medical devices.
ElectronicsHealthcareManufacturingEyewearHealth CareMedicalProduct Design
Responsibilities
Support the NA Quality Manager with QMS redevelopment and maintenance
Collaborate with cross functional teams and other departments to provide quality leadership, guidance, training, and support in QMS Implementation/execution
Support equipment qualification and development of plans and protocols (IQ/OQ/PQ)
Work closely with the project management team to ensure that our medical devices meet regulatory and quality requirements
Conduct risk assessments and participate in failure mode and effects analysis (FMEA) 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
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
Qualification
Required
5+ years hands-on experience in medical device quality engineering
Experience with QMS development is a plus
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 a medical device start-up environment is strongly preferred
ASQ certification as a Quality Engineer is a plus
Experience in performing QMS audits is preferred, with ASQ certification as a Quality Auditor being a plus
Experience in optics/opthalmics is a plus
Proficiency with Minitab, MS Outlook, MS Word, and MS Excel
Experience with ISO 14971 risk management is a plus
Bachelor's degree (Engineering, Science, or related field preferred) or commensurate offsetting experience in Quality Engineering
Benefits
Health/Dental/Vision/Disability Insurance
Tuition Reimbursement
401K plans
PTO and Paid Holidays
And more!
Company
Hoya Vision Care
Hoya Vision Care manufactures and supplies eyeglass lenses.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
S
Shigeru Yamanaka
Co-Founder
S
Shoichi Yamanaka
Co-Founder
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