Find & Apply For Validation Engineer Jobs in La Costa, California

Come join our growth-oriented medical device client as they expand their quality engineering team by adding a Sustaining Quality Engineer. The Sustaining Quality Engineer will apply quality engineering principles and problem-solving methods to support product quality, manufacturing processes, regulatory compliance, and continuous improvement within a highly regulated medical device environment. This role will partner closely with Manufacturing, R&D, Engineering, Operations, Supply Chain, and Quality teams to investigate quality issues, improve processes, maintain quality documentation, and support product and process changes. The ideal candidate has strong hands-on quality engineering experience, technical problem-solving skills, and a solid understanding of quality systems and manufacturing processes. Qualifications of the

Sustaining Quality Engineer:

Bachelor's degree in Engineering, Science, or a related technical discipline with 4+ years of relevant Quality Engineering, Manufacturing, or R&D experience; or Master's degree with 2+ years of relevant experience. Demonstrated experience leading root cause investigations, CAPA activities, nonconformance investigations, and material review/disposition processes. Experience with statistical analysis and quality tools such as Minitab or similar software. Knowledge of process validation and test method development/validation. Experience supporting new product introduction, product launches, manufacturing transfers, or production stabilization. Strong understanding of statistical process control (SPC), FMEA, risk management, root cause analysis, and structured problem-solving methodologies. Experience working within a regulated medical device or similarly controlled manufacturing environment. Familiarity with FDA and ISO quality requirements and regulated quality management systems. Experience with electromechanical, diagnostic, therapeutic, or other complex medical products is a plus. Strong written and verbal communication skills with the ability to work effectively across technical and functional teams. Responsibilities of the

Sustaining Quality Engineer:

Lead investigations into product, manufacturing, and process-related quality issues. Develop and maintain risk management documentation, including process risk assessments and FMEA activities. Support manufacturing and engineering activities associated with process and product transfers, including equipment and process qualification. Develop and maintain inspection procedures, test methods, sampling plans, and other quality documentation. Review and implement changes involving quality procedures, work instructions, test methods, manufacturing processes, product specifications, technical documentation, and labeling. Lead supplier evaluation, qualification, and ongoing quality activities. Partner with suppliers to resolve quality issues and manage supplier-related changes. Establish receiving inspection requirements and associated inspection and test methods. Lead CAPA investigations and ensure corrective and preventive actions are completed effectively and on schedule. Provide day-to-day quality support to cross-functional engineering and operations teams. Support internal and external audits, regulatory inspections, and associated compliance activities. Review equipment qualification activities and maintain documentation related to calibration and equipment control. Lead nonconformance investigations and resolution activities, including material review and product disposition. Support qualification of purchased components and materials and collaborate with inspection teams. Review and support environmental monitoring activities where applicable. Monitor and report quality metrics to identify trends, risks, and opportunities for improvement. Participate in continuous improvement and other quality-related projects as needed.

Occupational Code :

17-2112.00 Quality Engineer