QA Engineer - Medical Devices Quality & Compliance

Vybond Group; Franklin (KY); On-site; USD 65,000 - 90,000; Full time

Job summary

Vybond Group in Franklin, KY is seeking a QA Engineer to ensure medical product quality, safety and regulatory compliance. The role focuses on maintaining QMS aligned with ISO 9001:2015, ISO 13485, and FDA QSR, while driving risk reduction and championing continuous improvement on a manufacturing floor.

The ideal candidate will have 2–5 years in medical device quality engineering, strong analytics, and hands-on TMV/CAPA experience, with proficiency in Minitab and MS Office tools.

Qualifications

• Bachelor’s degree in Engineering, Applied Mathematics (with statistics), or related field; or 10 years of relevant experience.
• 2–5 years of quality engineering experience in the medical device or medical products industry.
• Proficiency with Minitab, Excel, Access, PowerPoint, and Word.
• Strong knowledge of FDA QSR, ISO 13485, and ISO 9001.
• Hands-on experience with TMV, CAPA, and nonconformance management.
• Strong analytical, communication, and leadership skills with the ability to influence cross-functional teams.

Responsibilities

• Quality Management System & Regulatory Compliance: Maintain and improve the QMS for medical products per ISO 9001:2015, ISO 13485, and FDA QSR; create SOPs and records.
• Risk Management & Continuous Improvement: Lead risk management using FMEA and drive Kaizen and problem-solving initiatives.
• Product & Process Quality: Prepare SPC charts, generate PPAP/IQ/OQ/PQ documentation, review MOC, and validate TMV.
• Customer Feedback & Complaint Management: Maintain complaint records and lead weekly review meetings; process RMAs.
• Training & Personnel Development: Develop training curricula and ensure competency evaluations and SOP compliance.

Skills

Analytical thinking

Communication

Leadership

Cross-functional collaboration

Education

Bachelor's degree in Engineering, Applied Mathematics (with statistics), or related field; or 10 years of relevant experience

Tools

Minitab

Excel

Access

PowerPoint

Word

Job description

Vybond Group in Franklin, KY is seeking a QA Engineer to ensure medical product quality, safety and regulatory compliance. The role focuses on maintaining QMS aligned with ISO 9001:2015, ISO 13485, and FDA QSR, while driving risk reduction and championing continuous improvement on a manufacturing floor.

The ideal candidate will have 2–5 years in medical device quality engineering, strong analytics, and hands-on TMV/CAPA experience, with proficiency in Minitab and MS Office tools.