Quality Assurance Manager - Advanced Manufacturing Operations

This 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 staff
• Ensure environmental monitoring and product sterility requirements are met.

Qualifications

• Bachelor’s degree in engineering or relevant field of study
• 8+ years of experience in medical device manufacturing and quality assurance
• 4+ years of experience in Quality Management Systems applied to manufacturing operations
• At least 2 years in a Quality Management Leadership role with direct reports
• Experience with internal and external FDA or 3rd party audits
• Knowledge 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 with

ERP 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 driving

cross-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.