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.