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.
• Review impact assessments when product changes are proposed.
• Review product design related reports (studies, protocols etc.) as required.  Provide feedback and coaching to product development and design assurance personnel.

Job responsibilities continued

Quality Operations

• Manage production Quality Assurance and Quality Engineering activities.
• Work closely with TMC Supplier Quality Management to manage KMI Supplier Quality requirements.
• Manage the equipment management program implementation and monitoring activities. Assure on-going monitoring is performed according to procedural requirements and that any issues or nonconformances are addressed in a timely manner.
• Manage the Engineering Change Control Review Board.  Review and approve change control documentation.  Ensure changes are conducted in a thorough and timely basis.
• Manage the Nonconformance Control and CAPA activities. Assure NCMRs and CAPAs are identified and addressed in a timely manner according to procedure requirements.  Work with TMC NC/CAPA team as required to ensure best practices are applied in KMI.
• Review of sterilization load documentation and assure compliance with validation requirements.
• Follow all established Environmental Health & Safety and Quality System policies, programs, rules and practices, including but not limited to product and patient safety, the health and safety of all associates as well as the environment and community at large.
• Other duties as assigned. 

Working Conditions/Physical Requirements

This position exists in an office environment. 

• Ability to travel on occasion.
• Availability to work evenings and weekends intermittently as needed.
   

Knowledge, Skills and Abilities (KSA)

• • Strong analytical problem-solving skills; ability to investigate complex issues using proven tools/methods, develop potential solutions, and implement fixes.
  • Demonstrated ability to distill complex technical information and explain to a non-technical audience. 
  • Demonstrated skill in technical writing. Ability to independently author all levels of documents. Ability to review and approve all levels of documents.
  • Strong verbal and written communication skills, ability to present to a broad audience (company personnel, suppliers, customers). Effective communication across all levels of the organization.
  • Thorough understanding of key regulations/standards for medical product manufacturing and development: 21 CFR 820, 21 CFR Part 11, 801, 803, 806, 807 and PMDA MO. 169.  ISO 13485 and ISO 14971.  Additional knowledge of EU MDR 2017/745 is preferred.
  • Demonstrated team leadership and development skills including training of functional personnel to applicable standards and career planning for team members.

Knowledge, Skills and Abilities (KSA) continued

• • Demonstrated ability to manage multiple and/or complex projects.
  • Proficiency using general business software like Microsoft Office and Windows® applications; Word, Excel, PowerPoint, Project.
• • Demonstrated ability to manage Engineers, Technicians, and co-ops.
  • Demonstrated ability to work well under pressure; organized and self-motivated; independent contributor and strategic thinker, planner.
  • Effective Root Cause Analysis through process skills; ability to make things happen.
  • Execution Minded; do what needs to be done and deliver on promises and critical communication.
  • Process validation experience; experience in validating product manufacturing processes to FDA compliance.
  • Ability to Maintain Quality Systems; collaborate in conceptualization and support implementation.
  • Responsiveness to assigned projects; respectful behavior traits, ownership and loyalty.

Qualifications/ Background Experiences

• • Bachelor’s Degree in a Sciences, Engineering or related discipline required, Master’s degree preferred; or equivalent combination of education, training and experience.   
  • Minimum of 10 years previous experience as a Quality professional supporting product development, product manufacturing, production and process control activities and Quality Systems support and maintenance required.
  • Minimum of 5 years’ experience managing and leading a team of professionals required.
  • Extensive experience with key regulations/standards for medical product manufacturing and development: 21 CFR 820, 21 CFR Part 11, 801, 803, 806, 807 and PMDA MO. 169.  ISO 13485 and ISO 14971.  Additional knowledge of EU MDR 2017/745 is preferred.
  • ASQ Certifications are desirable (CQM, CQA, CQE etc.).
  • Experience with catheter manufacturing and assembly methods preferred.
  • Knowledge of sterilization and biocompatibility desired.
  • Six Sigma DMAIC experience and certification are highly desirable.