Senior Account Executive (SaaS)

This Jobot Job is hosted by: Amanda PrestonAre you a fit? Easy Apply now by clicking the "Apply" button and sending us your resume.Salary: $110,000 - $135,000 per yearA bit about us:We are a growing, quality-driven manufacturer specializing in medical device and combination product production. Our team is committed to delivering safe, reliable, and compliant products that make a meaningful impact on patient care.With a strong foundation in regulated manufacturing, we focus on continuous improvement, operational excellence, and innovation across our processes. We pride ourselves on maintaining a collaborative, hands-on environment where employees are empowered to contribute, develop their skills, and take ownership of their work.Why join us?Clean, climate-controlled environment with a strong emphasis on quality and safetyStable schedule that supports work-life balanceCompetitive compensation and comprehensive benefits packageHealth, dental, and vision insurance401(k) with company contributionPaid holidays and generous PTOTuition reimbursement and ongoing training opportunitiesClear paths for career growth and advancementSupportive leadership and a team-oriented cultureJob DetailsWe are seeking a highly skilled Quality Engineer with experience in medical device, combination products, or Assembly, Labeling, and Packaging (ALP) manufacturing. This role is critical to ensuring product quality, regulatory compliance, and operational excellence across the full manufacturing lifecycle.You will play a key role in sustaining engineering efforts, continuous improvement initiatives, and the execution of quality systems, partnering closely with cross-functional teams across operations, engineering, and regulatory.ResponsibilitiesProvide Quality Engineering support for medical device operations, combination products, and ALP manufacturing linesEnsure compliance with FDA regulations, including 21 CFR Part 820, and applicable ISO standards such as ISO 13485 and ISO 14971Support and lead risk management activities, including FMEA and product risk assessmentsOversee processes related to sterile barrier packaging, labeling control systems, and drug-device interface considerationsLead or support investigations, root cause analysis, CAPA, and nonconformance resolutionCollaborate with cross-functional teams to drive process improvements, validation activities, and product lifecycle supportAssist with internal audits, external audits, and regulatory inspectionsDrive continuous improvement initiatives focused on quality, efficiency, and complianceQualifications5+ years of experience in medical device quality engineering, combination products, or ALP manufacturingExperience with assembly operations, packaging, and labeling processes in a regulated environmentKnowledge of sterile barrier packaging, labeling control systems, or drug-device interface requirementsStrong understanding of FDA QSR, ISO 13485, ISO 14971, and applicable regulatory frameworksExperience with risk management tools such as FMEAStrong analytical, problem-solving, and communication skillsBachelor's degree in Engineering or a related fieldInterested in hearing more? Easy Apply now by clicking the "Apply" button.