Quality Engineer

HOYA Group • Lewisville, TX

9d

About The Position

The Quality Engineer supports the Quality Team in establishing, maintaining, and continually improving the Quality Management System (QMS). The role provides quality leadership, guidance, training, and implementation support across cross-functional teams. It contributes to equipment and production-line validation, software and computer systems validation, investigations, risk management, documentation, design and development projects, audits, supplier quality, change management, and data-driven improvement activities.

The position calls for someone who can work independently while collaborating effectively, train employees and leadership on QMS modules and quality topics, and adapt to changing priorities. The employee is expected to uphold safety, integrity, quality, and organizational values while completing work accurately and on time. Travel of up to 10% may be required.

The work environment may involve moving mechanical parts, fumes or airborne particles, UV rays, and toxic or caustic chemicals. The noise level is usually moderate, though PPE may be required. Closed-toe shoes with heel support, safety glasses, and long-sleeve shirts may be required where needed. The employee must occasionally lift or move up to 30 pounds and is regularly required to sit and use hands to grasp and manipulate.

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 learn new software programs as required.
• Ability to travel up to 10%.
• Ability to manage communication and training using different training techniques.
• Ability to occasionally lift or move up to 30 pounds; regularly sit and use hands to grasp and manipulate.
• Basic understanding of the Injury and Illness Prevention Program and the Hazard Communication Program.
• Ability to follow applicable safety requirements, including wearing specified PPE or footwear where needed.

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 or certification as a Quality Auditor.
• Experience in optics or ophthalmic products.
• 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 failure mode and effects analysis (FMEA) activities; ensure risks are identified, evaluated, mitigated, and documented.
• Develop documentation, including quality 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.
• Perform internal QMS/process audits and support external audits, including ISO 9001, ISO 13485, and FDA audits, as applicable.
• 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 to protect self and others.
• Complete other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level