Senior Quality Engineer - Validation
Job Summary:
We are seeking a highly skilled and detail-oriented Senior Quality & Validation Engineer to lead and execute complex validation activities and support quality engineering initiatives across product development and manufacturing. This role plays a critical part in ensuring compliance with global regulatory standards and driving the reliability and robustness of processes and systems.
Key Responsibilities:
Lead the development and execution of validation strategies for processes, equipment, software, and systems, ensuring alignment with FDA QSR, ISO 13485, EU MDR, and other applicable regulations.
Author, review, and approve validation documentation, including protocols and reports (IQ/OQ/PQ) for new and existing equipment and processes.
Drive improvements in validation lifecycle management, ensuring consistency, traceability, and audit-readiness.
Serve as the subject matter expert (SME) for validation activities in cross-functional teams and during regulatory inspections.
Collaborate closely with R&D, manufacturing, regulatory affairs, and quality systems teams to ensure validation and quality deliverables are met on schedule.
Support and lead quality engineering initiatives including risk management (ISO 14971), CAPA, nonconformance investigations, and design controls.
Mentor junior engineers and contribute to technical training and process standardization across the organization.
Qualifications:
Bachelor's or Master's degree in Engineering, Life Sciences, or a related field.
7+ years of experience in the medical device or a similarly regulated industry, with a strong background in validation and quality engineering.
Demonstrated expertise in validation strategy, execution, and regulatory compliance for Class II/III medical devices.
Strong understanding of statistical tools, quality systems, and risk-based decision-making.
Effective communicator with a track record of collaboration in matrixed, cross-functional environments.