QMS Manager
Excelitas Technologies Corp. · Boulder, CO, US, 80301 · United States · On-site
Pay: USD 115,000 – 135,000 a year
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Excelitas is a global technology leader with more than 7,500 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 a Quality Management System Manager that be responsible for continous improvement and maintenance of the site QMS and in the support of manufacutring process improvements.
Main responsibilities:
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
Address and resolve customer complaints through effective corrective and preventative actions
Utilize 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 employees
Assist in the maintenance and training of the site on ISO standards and regulations according to site accreditations
Support and coordinate site Root Cause Investigations and Corrective and Preventative Actions (CAPA), including Supplier Corrective Actions (SCARS)
Conduct on-going QMS effectiveness reviews, quality performance analysis, and reporting site opportunities for improvement
Other duties as assigned
Requirements:
Bachelor 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,…