· 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.
· 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.
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.
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.
Other duties as assigned.
Knowledge, Skills and Abilities (KSAs)
- 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 (Quality System Regulation), 21 CFR 803 and 804 (MDR regulations), ISO 13485, ISO 14971, and MDD 93/42/EE.
- Demonstrated team leadership and development skills including training of functional personnel to applicable standards and career planning for team members.
- 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.
- Adaptability and flexibility in work schedule, and ability to work extended hours as necessary to achieve goals and accomplish tasks.
- 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 15 years previous experience as a Quality professional supporting product development, product manufacturing, production and process control activities and Quality Systems support and maintenance required, with a minimum of 8 years' experience in medical device industry.
- Minimum of 5 years' experience managing and leading a team of professionals required.
- Extensive experience and knowledge of FDA's Quality System Regulations, ISO 13485 and Medical Device Regulation required. Experience with other regulations is desired (Canada, Japan, etc.).
- 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