Senior Validation Engineer - V&V Lead

Advita Ortho, LLC; Gainesville (FL); Hybrid; USD 90,000 - 120,000; Full time

Job summary

Advita Ortho seeks a Senior Quality Engineer, Validation in Gainesville, FL to drive V&V planning and execution for medical devices. You will work across QA, engineering and regulatory teams to ensure compliant validation activities and robust documentation.

The role requires strong statistics, protocol development (IQ/OQ/PQ) and familiarity with FDA/ISO requirements, plus the ability to manage multiple validation projects independently and with teams.

Qualifications

• Bachelor's Degree required; Master's preferred
• Advanced level of technical software proficiency
• Excellent Quality System knowledge
• Strong time management and project management skills
• Experience writing IQ/OQ/PQ V&V protocols
• Working knowledge of FDA and ISO regulations
• Sterilization knowledge is a plus
• Independent and team work capability

Responsibilities

• Provide focused engineering assistance regarding V&V requirements for medical device processes, materials, equipment and methods
• Develop and execute robust inspection and test methods for V&V feasibility and qualification projects
• Lead or participate in validation of corporate software packages
• Apply statistical techniques to design and execute V&V activities
• Prepare documentation and execute V&V activities using risk-based approaches
• Coordinate training, protocol and documentation; support timely completion of V&V activities
• Maintain validation process auditing program and dashboards for monthly reviews
• Support cross-functional teams in device cleanliness and manufacturing V&V work
• Identify and communicate significant quality concerns early in V&V
• Participate in external supplier V&V activities and audits
• Lead company-wide validation related CAPAs

Skills

Advanced project management

Quality system knowledge

IQ/OQ/PQ V&V protocols

Statistical analysis

FDA/ISO regulations

Time management

Communication skills

MS Office proficiency

Education

Bachelor's Degree

Master's Degree preferred

Tools

Microsoft Office

Minitab

Job description

Advita Ortho seeks a Senior Quality Engineer, Validation in Gainesville, FL to drive V&V planning and execution for medical devices. You will work across QA, engineering and regulatory teams to ensure compliant validation activities and robust documentation.

The role requires strong statistics, protocol development (IQ/OQ/PQ) and familiarity with FDA/ISO requirements, plus the ability to manage multiple validation projects independently and with teams.