Principal Quality Assurance Engineer

• Location: Gainesville, Florida
• Type: Direct Hire
• Job #11841
• Salary: $145000

Location Type: On-Site

Summary of Position

The Principal Validation Engineer provides senior-level technical and cross-functional leadership for validation and verification (V&V) activities supporting medical device manufacturing, processes, equipment, materials, software, and test methods.

The position serves as a technical resource for validation principles, risk-based methodologies, statistical analysis, and regulatory expectations while providing guidance and mentorship to less experienced engineers.

Required Education & Experience

• Bachelor’s degree in Engineering, Science, Quality, or a related technical discipline with 10+ years of experience within the medical device industry, with significant involvement in validation and verification activities.
• Knowledge of biocompatibility requirements and testing associated with implantable medical devices, including evaluation of material and process impacts on biological safety.
• Familiarity with cleaning validation, bioburden reduction, sterilization validation, and microbial control strategies for medical devices.
• Exposure to gamma irradiation sterilization, including dose validation, dose mapping, bioburden considerations, and the evaluation of material or product impacts associated with sterilization.
• Advanced knowledge of process, equipment, material, test method, and/or software validation programs.
• Strong understanding of medical device quality systems and applicable FDA and ISO requirements.
• Working knowledge of risk management methodologies, including FMEA and process risk assessments.

Preferred Education & Experience

• Master’s degree in Engineering, Science, Quality, or a related technical field.
• ASQ certification such as Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or a related credential.
• Background developing and maintaining site-level or corporate validation master plans.
• Knowledge of validation requirements for enterprise or manufacturing software systems.
• Advanced understanding of statistical process control, process assurance, sampling plans, design of experiments, or other statistical methodologies.
• Familiarity with sterilization processes and associated analytical testing.
• Familiarity with product recalls, field actions, nonconformances, or other quality events requiring validation-related corrective actions.
• Ability to coordinate validation activities across multiple manufacturing locations or business units.
• Familiarity with validation project tracking systems, dashboards, metrics, and management reporting.
• Demonstrated ability to mentor and provide technical guidance to engineers and other technical personnel.