What are the responsibilities and job description for the Quality Assurance Manager position at Agile Search Inc.?
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
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.