Senior Validation Engineer, Medical Devices (V&V)

Advita Ortho; Gainesville (FL); On-site; USD 90,000 - 140,000; Full time

Job summary

Advita Ortho in Gainesville, FL is seeking a Senior Quality Engineer, Validation to provide hands-on V&V support for medical device processes and software. The role emphasizes planning, execution, risk-based approaches, and cross-functional collaboration to ensure compliance with FDA/ISO requirements.

You'll develop IQ/OQ/PQ protocols, maintain validation dashboards, participate in audits, and drive continuous improvement in corporate validation processes.

Qualifications

• Bachelor's degree in a relevant field required.
• Experience writing IQ/OQ/PQ V&V protocols.
• Working knowledge of FDA and ISO regulations.
• Excellent communication and organizational skills.
• Ability to work independently and in a team environment.

Responsibilities

• Provide focused, hands‑on V&V engineering support for medical device processes, materials, equipment and methods including project management, process design, document generation (IQ, OQ, PQ, SOPs, WIs and ETSs).
• Develop and execute robust inspection and test methods for V&V feasibility and qualification projects and stand-alone studies.
• Lead or participate in validation of corporate software packages ensuring adherence to industry requirements.
• Use statistical techniques to properly design and execute V&V activities.
• Prepare documentation and execute V&V activities using risk-based approaches (pFMEA, FMEA) and Good Engineering Practices (GEPs).
• Coordinate training, protocol and documentation retrieval to support timely execution and closure of V&V activities.
• Maintain validation process auditing program and the Validation Project Dashboard.

Skills

Quality Systems

V&V Protocols

PM Skills

FDA ISO Knowledge

Statistical Analysis

Microsoft Office

Communication Skills

Teamwork

Education

Bachelor's Degree

Master's Degree

Tools

Quality Management Software

Job description

Advita Ortho in Gainesville, FL is seeking a Senior Quality Engineer, Validation to provide hands-on V&V support for medical device processes and software. The role emphasizes planning, execution, risk-based approaches, and cross-functional collaboration to ensure compliance with FDA/ISO requirements.

You'll develop IQ/OQ/PQ protocols, maintain validation dashboards, participate in audits, and drive continuous improvement in corporate validation processes.