Senior Quality Engineer

Are you passionate about advancing medical technology and improving patient outcomes? Join a rapidly growing medical device company thats revolutionizing healthcare through innovative solutions.Your ImpactAs a Senior Quality Engineer, youll be at the forefront of ensuring product excellence and regulatory compliance for groundbreaking medical technologies. Your expertise will directly contribute to products that enhance patient care and safety.What Youll DoDrive quality initiatives across product development and manufacturing processesLead FMEA, CAPA, and root cause analysis investigationsCollaborate with cross-functional teams to implement quality management systemsEnsure compliance with FDA regulations and ISO standardsDevelop and maintain quality documentation and proceduresMentor junior team members and contribute to continuous improvement initiativesWhat You BringBachelors degree in Engineering, Life Sciences, or related field3+ years of quality engineering experience in medical devices/healthcareDeep understanding of FDA regulations, ISO 13485, and ISO 14971Hands-on experience with quality tools (FMEA, CAPA, Six Sigma)Strong analytical mindset and problem-solving capabilitiesExcellence in communication and team collaborationBonus PointsCQE certificationExperience with Class II or III medical devicesTrack record of implementing quality management systemsWhy This Role?Join a fast-growing company at the cutting edge of medical innovationWork with a collaborative team dedicated to improving healthcareCompetitive compensation and comprehensive benefits packageCareer growth opportunities in a rapidly expanding organizationReady to Make an Impact?If youre excited about shaping the future of medical technology while ensuring the highest quality standards, we want to hear from you. Send your resume and a brief note about why youre interested to with the subject line "Senior Quality Engineer - San Jose."Lumicity is proud to represent leading innovators in the medical device industry. We are committed to diversity and inclusion in our recruitment process.

Created: 2025-02-19