SigmaGraft, Inc. is currently seeking a highly motivated and talented individual for the Quality Manager position. We are looking for a highly driven individual that will be responsible for revising, implementing, and auditing the Total Quality Management System including developing quality procedures, implementing quality training, and communicating the results of quality efforts for the division. Additionally, you will…

• Prepares and manages all aspects of all ongoing and new regulatory submissions, both U.S. (e.g., PMA, IDE, 510(k), PMA Annual Reports, etc.), and international (e.g., CE Technical Files, Design Dossiers, APAC, etc.). Provide regular status updates and activity reports.
• Provide medical review and assure compliance with promotional materials in accordance with approved labeling, applicable regulations, and industry standards.
• Provides strategic direction and advice to project team regarding regulatory pathways and timelines for new and changed products/processes.
• Perform data gathering, analysis, and distribution of all quality related data to aid in identifying improvement opportunities
• Assist Department supervisors and managers to evaluate field problem data and develop action plans to prevent causes of problems
• Develop policies and procedures for inspection of various manufactured and purchased products
• Analyze/evaluate manufacturing processes to identify improvement opportunities and review new processes for possible integration into systems
• Maintaining the company’s Quality Management System
• Ensuring compliance with national and international standards and legislation
• Managing and maintaining controls and documentation relating to QMS
• Maintaining and organizing the company’s internal quality audit program and managing corrective and preventive action plans
• Managing the Internal/ External Audit process with internal customers and third parties certification and regulatory bodies

Required Qualifications
• Bachelor’s degree
• 5 or more years of experience in medical device industry preferred.
• Relevant work experience in a medical device, pharmaceutical, or aerospace field
• Previous experience with Quality Management System development, implementation, and monitoring
• Knowledge of quality systems, technical writing and training skills
• A strong working knowledge of Microsoft Excel, Microsoft Word, Microsoft PowerPoint and Microsoft Outlook
• Excellent communication, organizational, analytical and interpersonal skills
• Must be a person of passion and integrity who has the drive to excel and deliver exceptional results
Highly qualified candidates will also possess:
• Previous experience working with the ISO 13485 quality management system
• Previous experience with FDA cGMP
• Experience with product registration
• Experience with ISO and/or FDA audits
• The ability to solve practical problems or issues
• The ability to communicate and interact with co-workers in a positive manner
• The ability to work swiftly and accurately
• The ability to recognize and solve practical problems or issues