Site Senior Quality Manager

Job Title:Site Senior Quality ManagerFunction:Quality AssuranceNo. Reports5 Position OverviewThe Site Quality Manager plays a vital role in leading quality improvement initiatives at the site to enhance manufacturing operations, reduce the cost of poor quality, meet on-time delivery expectations, and ensure customer requirements are met. This position reports to the Site Leader with a dotted line to the Corporate Global VP of Quality. The role oversees various quality functions, including Quality Assurance (Incoming, In-Process, and Final), Quality Control, Quality Engineering, Document Control, Supplier Quality, Metrology, and Returned Material Authorizations. In addition, the site Senior Quality Manager is tasked with cultivating a culture of continuous improvement and operational excellence, with a focus on improving and optimizing the Quality Management System (QMS). Acting as the primary liaison for External and Internal Audits, the Site Senior Quality Manager ensures that product and process compliance not only meets but exceeds industry standards, customer expectations, and regulatory requirements. Specific Duties and Responsibilities

Lead quality improvement initiatives at the site to address the cost of poor-quality contributors Oversee multiple quality functions, including Quality Assurance, Quality Control, Document Control, Quality Engineering, Supplier Quality, Metrology, and Returned Material Authorizations 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 Improve and optimize the Quality Management System (QMS) to ensure effectiveness and efficiency while ensuring the standardization of procedures within Excelitas globally 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. Act as the Site Quality Management Representative and lead for internal and external audits to ensure adherence to industry standards, customer expectations, and compliance with regulatory requirements 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 Execute Lean and Six Sigma quality improvement projects using DMAIC principles 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 Coordinate the site Root Cause Investigations and Corrective and Preventative Actions (CAPA), including Supplier Corrective Actions (SCARS) Conduct on-going quality performance analysis, trending, and reporting for the site to identify opportunities for improvement Manage the site’s Material Review Board program for Non-Conforming Material Disposition Set up and uphold supplier quality benchmarks, carry out audits and oversee supplier performance to guarantee conformity to incoming material specifications

Qualifications:

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, or Defense Industry Environment Strong knowledge of quality standards and regulations (ISO 9001, ISO 13485, ISO 14971, IATF 16949, FDA 21 CFR 820)

Preferred

ASQ certified Quality Manager, Engineer, and/or ASQ certified Black Belt. 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 Experience in NPI (New Product Introductions) process management and product quality planning 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. Experience in Supplier Quality Management Excellent verbal and written skills, including proficiency in MS Office Suite of applications