Manufacturing Group Leader

Terumo•Davie, FL

1d•Onsite

About The Position

At Terumo Aortic, our mission is to transform the treatment of aortic disease worldwide. With our comprehensive portfolio of surgical, endovascular and hybrid technologies, we enable physicians to find the right fit for each patient anatomy. The company has over 1,250 associates around the world with manufacturing facilities in Glasgow, Scotland and Sunrise, Florida. Terumo Aortic is focused on the continuing development of new and innovative products driving the growth of the business globally. Associates are part of a stimulating and exciting environment in which they can develop their skills and achieve career goals. Working for the company, each associate’s role contributes greatly to helping to save or improve the lives of patients in over 100 countries worldwide. At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients. Join us and help shape wherever we go next! Advancing healthcare with heart www.terumoaortic.com Job Summary Working under supervision and following detailed verbal and written instructions, performs repetitive line assembly operations to produce medical device products. Associates are required to wear special garments while working in the controlled environment area (CEA). Group Leader is expected to have (or to obtain) certification in every process in assigned production area. Knowledge of SAP opening and closing orders. Is a leader in daily/weekly production meetings. Entrusted to cover production when the supervisor/manager is out and fill in on the production line as needed.

Requirements

5+ years’ experience of direct medical device manufacturing or related industry
1+ years in a supervisory/group lead role
Have good understanding of quality system requirements (e.g. 21CFR820, ISO13485), as well as all required Quality System documentation and record procedures.
Working knowledge of measurement techniques and quality standards.
Basic math skills
Basic PC skills and utilize common word processing and spread sheet software.
Work well with all departments of the company.
Able to work closely with Assemblers and gain/maintain their respect.
Able to communicate with Engineers

Nice To Haves

Certification in every process in assigned production area.
Knowledge of SAP opening and closing orders.
Preferred proficiency in SAP and Inventory management.

Responsibilities

Knowledge of each process and the ability to detect unsafe situations and practices and act.
Knowledge and application of Lean Manufacturing principles for a neat and orderly workspace
Daily Line set-up, ensuring tools, supplies, materials, and documentation are available for the scheduled run.
Identify, communicate, and respond to potential problems with materials, tools, etc. in a timely manner.
Manage the daily activities to meet productivity and quality objectives, and are to drive line performance improvement on an ongoing basis (promoting ongoing continuous improvement)
Assign tasks and procedures for the line – continuous workflow of product (ensures product is moving through the line and/or personnel are where the work is)
May participate in disciplinary action, performance/merit reviews, and general assignments and changes to assignments.
Line quality system compliance, including all applicable documentation, floor policies, auditing, assessment of the need for training, etc. He/she is responsible for the compliance of the lines’ equipment calibration and maintenance.
Train Assemblers and ensure adequate documented training exists, acceptable levels or understanding are present, and assemblers and operators comply with all training requirements.
Performance management – identifies areas of concern and provides/secures additional training as required.
Promotes cross training and job rotation.
Assists with creation of staffing plan based on goals and takt time.
Access resource needs (i.e., labour, equipment, etc.) and make recommendations when additional resources are required to ensure product availability.
Coordination of periodic Physical Inventory activities for his/her line or area.
Maintain awareness of the relevance and importance of activities performed and how they contribute to the achievement of quality objectives.
Work within the QMS always, ensure accurate completion of records and highlight issues to immediate supervisor any issues affecting quality.
Responsible to ensure facility, processes and documentation always remain in a state of audit readiness.
Take care of your own health and safety and that of others who may be affected by your actions.
Work co-operatively to highlight issues affecting Environmental Health and Safety