QMS Manager

ENABLE your future through light.Excelitas is a global technology leader with more than 7500 employees focused on delivering market-driven solutions to fulfill the illumination optical detection and imaging needs of OEMs and end-users across the biomedical semiconductor industrial consumer products scientific security defense and aerospace sectors.ENGAGE with us today and make your contribution to the future Join the team that leading technology companies turn to for cutting-edge photonic innovation. At Excelitas Technologies you are how we EXCEL.We are presently seeking aQuality Management System Manager that be responsible for continous improvement and maintenance of the site QMS and in the support of manufacutring process improvements.Main responsibilitiesOversee 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 globallySupport quality improvement initiatives at the site to address the cost of poor-quality contributorsCultivate a culture of continuous improvement and operational excellence within the organizationProvide cross-functional team leadership to drive quality and yield improvement initiativesEnsure that all manufacturing processes and finished products meet internal specifications customer requirements and regulatory compliance standardsPlan 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 requirementsAddress and resolve customer complaints through effective corrective and preventative actionsUtilize statistical tools and root cause analysis methods such as SPC Pareto Diagrams Affinity Diagrams Fault-Tree Analysis Design of Experiments Fish-Bone Analysis to drive quality improvements including training and guidance to site employeesAssist in the maintenance and training of the site on ISO standards and regulations according to site accreditationsSupport and coordinate site Root Cause Investigations and Corrective and Preventative Actions CAPA including Supplier Corrective Actions SCARSConduct on-going QMS effectiveness reviews quality performance analysis and reporting site opportunities for improvementOther duties as assignedRequirementsBachelor of Science degree required BS in Electrical Industrial Mechanical Engineering Quality Management or related field.5 years of experience in Quality Management within Advanced Manufacturing Bioscience Semiconductor Aerospace or Defense Industry EnvironmentStrong knowledge of quality standards and regulations ISO 9001 ISO 13485 ISO 14971 IATF 16949 FDA 21 CFR 820PreferredASQ certified Quality Manager ISO Lead Auditor Certification Technical WritingUnderstanding and familiarity with design history files change management manufacturing process control material review boards failure analysis correctivepreventive actions and verification testing per cGMP requirements and FDA QSR ISO 9001 ISO13485 ISO 14971Experience in NPI New Product Introductions process management and product quality planningFormal training in statistical techniques in a manufacturing environment with Six Sigma training and certificationKnowledge and experience with continuous improvement techniques such as Lean Enterprise Six Sigma Kaizen SPC etc.Experience in Supplier Quality ManagementExcellent verbal and written skills including proficiency in MS Office Suite of applicationsBenefits start day 1 Medical Dental Vision 401K Holiday Pay PAID MaternityPaternity leave Tuition Reimbursement Long-term and Short-term disability.Pay Range 115000 - 135000 per year depending on experience.Excelitas is a global technology leader with more than 7500 employees focused on delivering market-driven solutions to fulfill the illumination optical detection and imaging needs of OEMs and end-users across the biomedical semiconductor industrial consumer products scientific security defense and aerospace sectors.ENGAGE with us today and make your contribution to the future Join the team that leading technology companies turn to for cutting-edge photonic innovation.At Excelitas Technologies you are how we EXCEL.Our facility in Boulder Coloradohas key functions in Research and Development Operations Production and other disciplines. This facility specializesin the manufacturing of ultra-precision optical components optical thin film coatings and optical sub-assemblies for demanding applications in lasers materials processing instrumentation life sciences avionics and defense.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.LI-FM1 LI-OnsiteThis position requires the use of information which is subject to the International Traffic in Arms Regulations ITARVisa sponsorship is not available for any position at ExcelitasEqual OpportunityAffirmative Action EmployerMinoritiesFemalesDisabilityVeteranGender IdentitySexual OrientationExcelitas is seeking leaders and innovators to join our global team Visit httpsjobs.excelitas.com