Quality Engineer — QMS Lead & Compliance

HOYA Vision Group; Lewisville (TX); On-site; USD 90,000 - 120,000; Full time

Job summary

HOYA Vision Group in Lewisville, TX seeks a Quality Engineer to support QMS establishment, maintenance, and continuous improvement for medical device processes. You will lead validation activities IQ/OQ/PQ, participate in audits (FDA ISO13485), manage CAPAs, and drive data-driven improvements across design and development projects.

Strong analytical skills, familiarity with ISO 14971 risk management, and proficiency with Minitab, MS Excel, Word and Outlook are required; occasional travel up to

Qualifications

• 5+ years of hands-on experience in medical device quality engineering.
• Experience with QMS development and implementation is a plus.
• Experience with FDA-regulated products and ISO 13485 certified QMS.

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 in QMS implementation/execution.
• Support validation activities, including IQ/OQ/PQ and TMV for equipment and production line process validation.
• Support software validation and computer systems validation activities as required.
• Own and support CAPAs, deviation, and nonconformance investigations.
• Conduct risk assessments and lead failure mode and effects analysis (FMEA) activities. Ensure risks are identified, evaluated, mitigated, and documented.
• Develop documentation (i.e., quality plans, procedures) to ensure compliance with applicable regulations.
• Serve as the quality representative on Design and Development projects supporting completion of DHF documentation.
• May perform internal QMS/process audits and support external audits (i.e., ISO 9001, ISO 13485, FDA) to ensure compliance with quality and regulatory requirements.
• Support supplier quality evaluations and monitoring (audits, SCAR, and others).
• Participate in change management activities.
• Perform data analysis and KPI monitoring to identify trends and opportunities for improvement.
• All other duties as assigned.

Skills

QMS development

Quality engineering

FDA regulations

ISO 13485

Six Sigma Green Belt

Minitab

MS Excel

MS Word

MS Outlook

Education

Bachelor’s degree in engineering or science

Tools

Minitab

MS Excel

MS Word

MS Outlook

Job description

HOYA Vision Group in Lewisville, TX seeks a Quality Engineer to support QMS establishment, maintenance, and continuous improvement for medical device processes. You will lead validation activities IQ/OQ/PQ, participate in audits (FDA ISO13485), manage CAPAs, and drive data-driven improvements across design and development projects.

Strong analytical skills, familiarity with ISO 14971 risk management, and proficiency with Minitab, MS Excel, Word and Outlook are required; occasional travel up to