Preclinical V&V Specialist (34669)
RemoteJacksonville, Florida, United States or Florida, United States
Job Summary
Plan, execute, and document verification and validation activities for medical devices in development, including biocompatibility, environmental, and performance testing. Develop V&V protocols, test plans, and reports aligned with design control and risk management processes while managing external labs and contractors. Ensure compliance with standards such as ISO 10993 and FDA requirements by compiling test plans, risk assessments, and supporting regulatory submissions. Coordinate cross-functional activities with R&D, Quality Assurance, and Regulatory Affairs to integrate V&V into the product lifecycle and assess product change requests for biocompatibility impact.
Required Qualifications
- BS degree in relevant scientific disciplines, such as material science, toxicology, chemistry, biology or similar
- 2-4 years experience in the Medical Device Industry
- Experience in Biocompatibility
- Familiarity with application of ISO 10993
- Experience with FDA Interactions
- Previous experience leading projects and presenting recommendations based on technical inputs from multiple and varied functions
- Must be within 50 miles of Jacksonville, FL
- Maintains high integrity and confidentiality of company and department information
- Ability to work effectively with all levels of internal and external associates, customers, and colleagues
- Excellent interpersonal skills with the ability to effectively communicate at all levels internally as well as externally
- Ability to follow through on issues, make informed decisions that comply with policies and procedures, complete tasks and problem-solve
- Ability to work with minimal supervision
- Ability to manage multiple priorities
- Ability to organize and track multiple projects in a detail-oriented and self-directed manner
- Ability to work both independently and within a team environment
- Possess intermediate to advanced level knowledge of Microsoft Office
- Typing/computer keyboard
- Utilize computer software
- Retrieve and compile information
- Maintain records/logs
- Verify data and information
- Organize and prioritize information/tasks
- Operate office equipment
- Verbal communication
- Written communication
- Research, analyze and interpret information
- Investigate, evaluate, recommend action
- Sitting for extended periods
- Standing for extended periods
- Extended periods viewing computer screen
- Walking
- Reading
- Speaking
- Hear/Listen
- Maintain regular, punctual attendance
- KLS Martin is a drug-free employer
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.