Sr. Manager, Quality Kalila

Job Summary

Senior Manager, Quality has primary responsibility for establishing and maintaining compliance of Kalila Medical’s (KMI) processes and procedures to the FDA (US) and PMDA(Japan) Quality System Regulations, and ISO 13485.  This role will manage, lead and mentor the Kalila Medical Quality team. 

Senior Manager, Quality will manage and maintain compliance for quality systems as defined in the company’s Quality Manual including Management Oversight, Supplier Controls, Equipment Controls, Nonconformance Management, CAPA, Complaint Handling and Adverse Event Reporting, Corrections and Removals, Document Control, Lot Release, Training, Production & Process Control, Design Controls/Assurance, Risk Management etc.

Senior Manager, Quality will manage the collection, analysis, maintenance and presentation of quality data/metrics to monitor and assure the overall suitability and effectiveness of KMI’s Quality System.  Shall develop and implement strategies and supporting initiatives to promote the effectiveness and continual improvement of KMI’s Quality Management System.

Senior Manager, Quality will be a collaborative member on the KMI Leadership Team and will serve as the Management Representative for KMI.  In addition, will be a member of Terumo Medical Corporation (TMC) Quality Management Leadership Team and will be responsible to drive coordinated activities across TMC operations.
Senior Manager, Quality will also provide Quality Engineering / Design Assurance support to R&D as they develop products for commercialization through KMI’s Quality Management System. Salary range: $148,200 - $224,200 and 15% bonus.

Job Details/Responsibilities

Overall Management:

• Manage and lead a high performing Quality team, that consists of Quality Engineers, Technicians and Specialists. 
• Develop and coach Quality associates to maximize potential and enhance engagement.
• Hire, train, and set goals with the team that align with Organizational and Functional objectives.
• Be an active participant on cross-functional teams, representing the Quality function.

Quality Systems:

• Support the continual improvement of KMI’s Quality System and Quality Policy.
• Develop and manage KMI’s Strategic Quality Plan.  Ensure this plan is aligned with TMC’s quality objectives and Terumo Corporation Quality Policies. 
• Support KMI’s strategic goals and supporting initiatives.
• Drive an effective Management Review process to ensure the suitability and effectiveness of KMI’s Quality Management System.
• Manage the implementation, maintenance and governance of KMI’s Quality Management System to ensure compliance with applicable regulations and Terumo’s Quality Policies.
• Maintain compliance audit program.
• Manage compliance training program including role-based curriculum, training content, program metrics etc.
• Ensure KMI’s CAPA program effectiveness.  Maintain the CAPA portfolio, governance board, program metrics etc.
• Support complaint handling/adverse event reporting activities that may include returned product investigations.
• Provide communications to management of concerns involving compliance and/ or product quality.

Job Responsibilities (continued)

New Product Introduction/ Design Control Quality

• Assure design control activities are performed in accordance with established procedures and design control regulations.
• Participate in product development design reviews.
• Participate in risk management activities including risk assessments, risk manage file reviews etc.
• Participate in design history file (DHF) audit reviews.
• Perform technical review and approval of design verification test protocols/ reports.