Quality Assurance Manager
Agile Search Inc. - Mansfield, MA
Apply NowJob Description
Quality Assurance Manager - Advanced Manufacturing OperationsThis search is for a global medical technology company expanding operations (Advanced Manufacturing Center of Excellence) in Massachusetts. Key Responsibilities:Serve as subject matter expert in quality engineering and quality systems for the site.Provide value to continuous improvement activities in product and process quality, validation, defect analysis, CAPA, and internal audits.Ensure compliance with FDA, ISO, EN, and MDR standards, leading audits, CAPA processes, and driving quality improvement initiatives.Analyze field failure data to identify trends, make recommendations for design or process improvements, and reduce costs and service impact.Host and manage internal and external audits, ensuring quality system adherence across global operations.Lead the quality team, provide training, and foster a collaborative, high-performance culture. Drive continuous improvement across the quality system.Ensure compliance with FDA, ISO, and MDR regulations, supporting internal and external audits.Lead initiatives to improve quality systems, lean manufacturing, and Six Sigma activities.Analyze quality data, prepare inspection procedures, and review engineering changes.Indirectly supervise and manage technical staffEnsure environmental monitoring and product sterility requirements are met.QualificationsBachelor's degree in engineering or relevant field of study8+ years of experience in medical device manufacturing and quality assurance4+ years of experience in Quality Management Systems applied to manufacturing operationsAt least 2 years in a Quality Management Leadership role with direct reportsExperience with internal and external FDA or 3rd party auditsKnowledge and experience with sterilization, clean rooms, machining, and injection molding Certifications: Lead Auditor training for ISO 9001/ISO 13485, CQE or CQM preferred Skills: Strong knowledge of FDA regulations, ISO standards (13485, 14971), and experience withERP systems like SAP. Proficiency in statistics, SPC and other quality engineering tools. Leadership: Proven ability to lead and mentor teams, delivering high-quality results and drivingcross-functional collaboration.Equal Opportunity: Agile Search is committed to considering exceptional individuals from all walks of life, regardless of identification of race, religion, gender, national origin, age, disability, marital status, or veteran status.
Created: 2025-02-04