What are the responsibilities and job description for the Director, Quality Engineering (Transfers) position at Terumo Neuro?
Job Description
Create, lead, and manage the Quality Engineering organization responsible for Product Transfers and Sustaining Operations. Oversee the execution of related projects for transfers, including, but not limited to, new product introduction, site-to-site product transfers, and manufacturing process improvements. Develop and implement strategies to enhance product quality and compliance and serve as a conduit to streamline the transfer of products. Collaborate cross functionally to ensure products are developed with a focus on critical quality and manufacturability, while effectively transferring robust processes from R&D to manufacturing and between manufacturing sites globally. Manage a team to lead multiple quality operations projects that support the manufacture of medical devices. Job duties:
US - United States
Create, lead, and manage the Quality Engineering organization responsible for Product Transfers and Sustaining Operations. Oversee the execution of related projects for transfers, including, but not limited to, new product introduction, site-to-site product transfers, and manufacturing process improvements. Develop and implement strategies to enhance product quality and compliance and serve as a conduit to streamline the transfer of products. Collaborate cross functionally to ensure products are developed with a focus on critical quality and manufacturability, while effectively transferring robust processes from R&D to manufacturing and between manufacturing sites globally. Manage a team to lead multiple quality operations projects that support the manufacture of medical devices. Job duties:
- Develop and execute comprehensive strategies to enhance product quality and compliance aligned with the organization’s goals and objectives with a focus on product transfers, manufacturing process development and improvement, and sustaining operations.
- Provide strategic guidance and directions to the team, ensuring efficient resource allocation and effective project delivery.
- Foster a culture of collaboration, accountability, knowledge sharing, and continuous improvement.
- Work closely with cross-functional leaders to establish a streamlined process for product transfers to standardize and support all transfers.
- Establish and execute processes to maintain alignment with downstream manufacturing sites to communicate technical needs and required preparations effectively.
- Establish project management best practices, tools, and methodologies to enhance project outcomes and efficiency.
- Conduct regular reviews of projects to identify risks, issues, and dependencies and implement mitigation strategies.
- Effectively communicate, collaborate, and execute projects with other departments, internally and externally, including, but not limited to, R&D, Regulatory Affairs, Manufacturing, New Product Introduction (NPI), Business Excellence (BeX), and Marketing to achieve Quality Engineering and business goals.
- Participate and provide regular updates on project status, milestones, and risks to senior leadership and key stakeholders.
- Optimize resource utilization across multiple projects, balancing priorities and addressing conflicts.
- Identify opportunities for resource development and training to enhance the team’s capabilities.
- Stay current with industry trends, regulations, and best practices in medical device project management, and apply them to improve project delivery.
- Implement project performance metrics and dashboards to track progress, identify areas for improvement, and report on key performance indicators.
- Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
- Perform additional duties and responsibilities as assigned.
- Bachelor's degree in a relevant field of study.
- A minimum of twelve (12) years of relevant professional experience in Quality and/or Manufacturing within the medical device industry.
- A minimum of five (5) years of management or leadership responsibility/experience.
- Strong statistical background with hands-on implementation of related best practices.
- Exceptional leadership, written and verbal communication, and stakeholder management skills.
- Proficiency in project management software and tools and MS Office Suite, including Word, Excel, Outlook, and Teams.
- Exceptional organizational and project management skills, and a deep understanding of management.
- Ability to work in a fast-paced, innovative, and market-driven organization.
- Advanced degree in a relevant field of study.
- Strong knowledge of Quality Management Systems, medical device development, regulatory requirements, manufacturing process development, and best practices.
- Demonstrated risk management skills.
- CQE and CQM certification from a reputable learning organization.
- Project Management Professional (PMP) certification.
- Excellent analytical skills to produce accurate data and solution proposal.
- Ability to use computer-assisted engineering, design software, and equipment to perform engineering and design tasks.
- Computer software and coding skills.
US - United States
