Senior Quality Engineer
About The Position
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 our Ramsey, MN location! Salary Range: $120K+ 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: 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
Requirements
- 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
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
Benefits
- Health/Dental/Vision/Disability Insurance
- Tuition Reimbursement
- 401K plans
- PTO and Paid Holidays
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
