Contract Senior Quality Engineer

Join a cutting-edge team in the medical device industry dedicated to enhancing patient outcomes through engineering excellence and precise regulatory adherence. As a Senior Quality Engineer , you will be instrumental in assuring compliance, reliability, and performance of transformative technologies while supporting product development and ongoing manufacturing operations.

Your Key Responsibilities

• Establish and maintain quality controls, processes, and analytical methods to assure products meet specifications.
• Lead verification and validation (V&V) testing activities, including protocol design, execution, data analysis, and detailed reporting.
• Contribute to design control efforts and engage in cross-functional reviews for new product developments and significant design modifications.
• Implement statistical analysis to enhance process stability and product quality through data-driven decisions.
• Work collaboratively with manufacturing teams and suppliers to uphold standards and improve practices related to assembly, testing, and documentation.
• Facilitate supplier qualification , incoming inspections, and initiatives aimed at process improvement.
• Engage in risk management activities (ISO 14971) and ensure adherence to quality management systems and regulatory standards.
• Assist in internal and external audits (FDA, ISO), manage nonconformance investigations, and drive CAPA initiatives.
• Evaluate field issues and deviations, conducting root cause analysis, and executing effective corrective measures.

What You Bring to the Table

• A Bachelor’s degree in Biomedical, Mechanical, Chemical, or a related Engineering field .
• 3-5+ years of experience in a medical device quality engineering capacity.
• Proficient understanding of FDA QSR, ISO 13485, ISO 14971 , and risk-based quality systems.
• Hands-on experience with verification testing, statistical analysis, and process validation .
• Excellent communication skills; capable of crafting concise reports, presenting findings, and collaborating with diverse teams.
• Proficiency in Excel, Minitab, MATLAB , or similar analytical tools.
• A detail-oriented and organized approach, with a proactive outlook towards continuous improvement.