Quality Management System Manager

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.
• Aid 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.

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, or Defense Industry.
• Strong knowledge of quality standards and regulations (ISO 9001, ISO 13485, ISO 14971, IATF 16949, FDA 21 CFR 820).
• PREFERRED: 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.
• 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.
• Experience in Supplier Quality Management.
• Excellent verbal and written skills, including proficiency in MS Office Suite of applications.