Quality Engineer

HOYA Vision Care•Lewisville, TX

7h•Onsite

About The Position

HOYA Vision Care is hiring a Quality Engineer at its Ramsey, Minnesota location. The Quality Engineer ensures that products, processes, and quality systems comply with internal requirements, customer expectations, and regulatory standards. The role supports establishment, maintenance, and continuous improvement of the Quality Management System (QMS), risk management, validation and qualification programs, audits, CAPA investigations, and improvement initiatives aligned with ISO 13485, FDA requirements, and other applicable regulations. The Quality Engineer works with Operations, Engineering, R&D, and global and regional Quality teams to advance product quality, process effectiveness, compliance, and customer satisfaction for ATC (R&D), Mass Operations, and Rx functions. The position supports QMS activities, validation, investigations, risk assessments, audits, supplier quality, change management, data analysis, and production-line quality needs.

Requirements

Bachelor’s degree in Engineering, Science, or a related field, or commensurate offsetting experience in Quality Engineering.
At least 5 years of hands-on experience in medical device quality.
Experience with FDA-regulated products and an ISO 13485-certified QMS.
Experience in product development, including implementing appropriate controls.
Working knowledge of statistics.
Proficiency with Minitab, MS Outlook, MS Word, and MS Excel.
Attention to detail and excellent problem-solving skills.
Excellent written and verbal communication skills.
Ability to identify potential roadblocks and provide innovative solutions.
Ability to work independently and collaboratively in a team environment.
High level of integrity and professionalism.
Ability to learn new software programs as required.
Ability to travel up to 10%.
Ability to manage communication and training using different training techniques.
Willingness to learn and grow, and ability to thrive amid shifting priorities.

Nice To Haves

Experience with QMS development.
Six Sigma Green Belt certification or higher.
Working knowledge of FDA regulations, including 21 CFR 820, and other relevant standards.
Experience in a medical device start-up environment.
ASQ certification as a Quality Engineer.
Experience performing QMS audits; Quality Auditor certification is a plus.
Experience in optics or ophthalmics.
Experience with ISO 14971 risk management.

Responsibilities

Support the Quality Team with QMS establishment, maintenance, and continuous improvement.
Collaborate with cross-functional teams to provide quality leadership, guidance, training, and support for QMS implementation and execution.
Support equipment and production-line process validation activities, including IQ/OQ/PQ and TMV.
Support software validation and computer systems validation as required.
Own and support CAPA, deviation, and nonconformance investigations.
Conduct risk assessments and lead FMEA activities; ensure risks are identified, evaluated, mitigated, and documented.
Develop quality documentation, including quality plans and procedures, to ensure regulatory compliance.
Serve as the quality representative on Design and Development projects and support completion of DHF documentation.
Perform internal QMS and process audits, and support external audits, including ISO 9001, ISO 13485, and FDA audits.
Support supplier quality evaluations and monitoring, including audits and SCARs.
Participate in change management activities.
Perform data analysis and KPI monitoring, and identify trends and opportunities for improvement.
Develop PCPs and support production lines as needed.