Quality Engineer

HOYA Vision Care•Lewisville, TX

10d

About The Position

The Quality Engineer supports the Quality Team in establishing, maintaining, and continuously improving the Quality Management System (QMS). The role provides quality leadership, guidance, training, and support to cross-functional teams and contributes to quality and regulatory compliance across product development, production, suppliers, and business processes. The position supports equipment and production-line process validation, including IQ/OQ/PQ and TMV, as well as software and computer systems validation. It owns and supports CAPAs, deviations, and nonconformance investigations; conducts risk assessments and leads FMEA activities; develops quality documentation; and serves as the quality representative on Design and Development projects, including supporting Design History File (DHF) documentation. The role may conduct internal QMS and process audits and support external audits, including ISO 9001, ISO 13485, and FDA audits. It also supports supplier quality evaluations and monitoring, participates in change management, and analyzes data and monitors KPIs to identify trends and improvement opportunities. The successful candidate works independently and collaboratively, trains employees and leadership on QMS modules and quality topics, and adapts to shifting priorities. The position requires attention to detail, problem-solving, strong communication, integrity, professionalism, and the ability to learn new software. Travel may be required up to 10%. The role is in a work environment that may include moving mechanical parts, fumes or airborne particles, UV rays, and toxic or caustic chemicals. Employees regularly sit and use their hands to grasp and manipulate objects, and may occasionally lift or move up to 30 pounds. Safety practices and appropriate PPE may be required.

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 engineering.
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 in a collaborative team environment.
Ability to operate with a high level of integrity and professionalism.
Ability to learn new software programs as required.
Ability to manage communication and training using different training techniques.
Ability to travel up to 10%.
Basic understanding of the Injury and Illness Prevention Program and the Hazard Communication Program.
Ability to occasionally lift and/or move up to 30 pounds.

Nice To Haves

Experience with QMS development and implementation.
Six Sigma Green Belt or higher certification.
Working knowledge of FDA regulations (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 in QMS implementation and 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 investigations, and nonconformance investigations.
Conduct risk assessments and lead FMEA activities; ensure risks are identified, evaluated, mitigated, and documented.
Develop quality documentation, including plans and procedures, to ensure compliance with applicable regulations.
Serve as the quality representative on Design and Development projects and support completion of DHF documentation.
May 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 to identify trends and opportunities for improvement.
Train employees, including leadership teams, on newly implemented QMS modules and other quality-related topics.
Implement safety practices in daily work.
Travel up to 10%.
Perform other duties as assigned.