Hiring: QMS Manager Company: Excelitas Technologies Corp. Location: Boulder, CO Job Posted Time: 2026-09-12 10:19:52 Target Skills & Keywords : Assembly, Regulatory Compliance About the job Experience: •5+ years of experience in Quality Management within Advanced Manufacturing, Bioscience, Semiconductor, Aerospace, or Defense Industry Environment Required Skills: •Oversee all Quality Management System functions, including Document Control, Internal QMS Audits, Customer & Supplier Audits, Returned Material Authorizations, and Customer Complaints. •Improve and optimize the Quality Management System (QMS) to ensure effectiveness and efficiency while ensuring the standardization of procedures within Excelitas globally •Support quality improvement initiatives at the site to address the cost of poor-quality contributors •Cultivate a culture of continuous improvement and operational excellence within the organization •Provide cross-functional team leadership to drive quality and yield improvement initiatives •Ensure that all manufacturing processes and finished products meet internal specifications, customer requirements, and regulatory compliance standards •Plan, coordinate, and actively engage in new product introductions (NPI), product qualifications, design verifications, and risk assessments, which encompass process failure mode and effects analysis. •Ensure adherence to ISO standards such as ISO 9001, ISO 13485, ISO 14971, and FDA 21 CFR 820 according to site accreditation requirements Qualifications: •Bachelor of Science degree required, BS in Electrical, Industrial, Mechanical Engineering, Quality Management, or related field. •Strong knowledge of quality standards and regulations (ISO 9001, ISO 13485, ISO 14971, IATF 16949, FDA 21 CFR 820) •ASQ certified Quality Manager, ISO Lead Auditor Certification, Technical Writing •Understanding and familiarity with design history files, change management, manufacturing process control, material review boards, failure analysis, corrective/preventive actions, and verification testing per cGMP requirements, and FDA QSR / ISO 9001/ ISO13485/ ISO 14971 •Formal training in statistical techniques in a manufacturing environment with Six Sigma training and certification •Knowledge and experience with continuous improvement techniques such as Lean Enterprise, Six Sigma, Kaizen, SPC, etc. •Excellent verbal and written skills, including proficiency in MS Office Suite of applications •This site offers capabilities that include substantial design and engineering resources, comprehensive optical fabrication and coating capabilities, advanced assembly technology and an extensive in-house metrology lab. •This position requires the use of information which is subject to the International Traffic in Arms Regulations (ITAR) •Visa sponsorship is not available for any position at Excelitas Compensation: •$115,000 - $135,000 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!