Manager, Production Quality Engineering

Requisition ID:  31924  

 

At Terumo Blood and Cell Technologies, our 7,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world.

 

We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve.

 

With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Consider joining our team and unlock your potential. 

The Production Quality Engineering Manager will oversee and provide leadership for the Production Quality Engineering, Validation, and In-process testing teams.  This role is integral in driving quality improvements in manufacturing, maintaining compliance to standards and regulations, and ensuring product testing is completed in timely and consistent manner.  The Production Quality Engineering Manager will be the subject matter expert for these areas and will own the ongoing maintenance, execution, and improvement of the QMS for these areas.

 

ESSENTIAL DUTIES

• Manages and provides leadership for the team’s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.
• Responsible for identifying and implementing projects and initiatives to reduce defects, improve product quality, and streamline quality processes.
• Manages the Nonconformance process to ensure the appropriate investigation of issues, timeliness of record completion, and drives a reduction in the number of nonconformances generated.
• Collaborates with production, process engineering, R&D, and contract manufacturers as appropriate to ensure changes and nonconformances are handled appropriately.
• Actively participates in the annual budgeting process and is responsible for managing an operation within budgetary guidelines.
• Develops, maintains, and monitors KPIs for areas of responsibility.
• Analyzes quality data for trends and presents this analysis to the management team.
• Understands and implements FDA or other regulatory requirements as necessary.
• Serves as expert and main point of contact for regulatory/compliance issues within areas of responsibility, including serving as Subject Matter Expert for areas of responsibility during audits and inspections.
• Manage, continuously improve, and provide oversight for validation processes, in-process testing, and quality engineering processes.
• Plans, guides, and reviews projects and work from the team to ensure that the desired outcome is achieved.
• Utilizes technical skills to evaluate proposed solutions, adaptations, and modifications to projects.
• Acts as an internal champion for quality initiatives aimed at improving business systems and compliance; may be the primary representative for Quality on projects.
• Interfaces with Quality Engineering and project teams from other Terumo BCT locations and regions.

 

MINIMUM QUALIFICATION REQUIREMENTS

 

Education

• Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
• Bachelor of Science Degree in Engineering, preferred.

 

Experience

Minimum 10 years experience.

 

Skills

• Strong leadership capabilities to ensure continuous guidance, coaching, and directing teams to success in their tasks and professional development.
• Strong project management, problem-solving, resource management skills.
• Demonstrated skills in developing, coaching, and training others in an organizational setting.
• Excellent in collaboration in working with cross-functional groups.
• Strong interactive skills in cross functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross functional team members, team behavior, and support for subordinates, junior engineers, technicians, and management.
• Represents the organization as the main technical contact on projects. Interacts with senior level associates on significant technical matters often requiring coordination between organizations.
• Driver for acquiring resources and building consensus across teams.
• Solicits and accepts the ideas of others, as well as actively contributes to an environment