Manufacturing Group Leader 2nd Shift

Date:  Mar 21, 2024
Req ID:  1267
Location: 

sunrise, FL, US

Company: 
Department: 

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.

www.terumoaortic.com

JOB TITLE

 

Production Supervisor

 

DEPARTMENT

 

Manufacturing

JOB CODES

Exempt

MAIN PURPOSE OF JOB AND OBJECTIVES

 

 

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

 

Responsible for the manufacturing assemblers including leading other manufacturing group leaders. This includes meeting daily manufacturing commitments, managing D/L and head counts to budgeted levels, track productivity, ensure quality system compliance and develop personnel to take on additional responsibilities.

 

 

POSITION IN ORGANISATION

 

Position in organisation can be found on the Organisational Chart via the company intranet.

KEY DUTIES

 

 

 

 

  • Supervision of Group Leaders and Direct Labor employees in managing goals and expectations.  He/she will insure staffing and indirect support is at adequate levels to achieve established production plans and quality objectives.  Management of employee safety issues.  Supervisor will manage overtime according to approved plans.
  • Operator Training and facilitation of employee involvement in continuous improvement initiatives.  Ensure communication of complaints and customer feedback as well as general organizational priorities
  • Drive teamwork within team.
  • Completion of Performance/Merit reviews & Compensation Recommendations
  • Manage time and attendance.
  • Human resource management including completion of performance and merit reviews, compensation recommendations, management of disciplinary issues, as well as maintaining high motivation and morale, including appropriate reward and recognition activities as appropriate.
  • Provide effective feedback to team as needed to develop excellence, including appropriate reward and recognition activities as appropriate.
  • Assist Manufacturing Manager in managing:
    • Manufacturing design and flow, as applicable
    • SAP integration project
    • Other integration projects
    • Quality and Compliance (NCR, Audit response, CAPA)
  • Willing to workday shift, night shift, and/or weekends plus extended hours.
  • Supervision of Group Leaders and Direct Labor employees in managing goals and expectations.  He/she will insure staffing and indirect support is at adequate levels to achieve established production plans and quality objectives.  Management of employee safety issues.  Supervisor will manage overtime according to approved plans.
  • Ensure compliance to quality system regulations (21CFR820, ISO13485) for areas of responsibility and training for production operations.  Ensure compliance to in-process inspections as well as general procedures such as Workstation Practices and Controlled Environment Area Procedures for personnel.  Routine quality system audits are to be performed.
  • Manage manufacturing interruptions and quality and scrap events ensuring management awareness and request for adequate technical resources.  The Supervisor will participate in the initiation, creation, and execution of various process improvement evaluations, validations, and documentation necessary for implementation.
  • Participation on the production planning in support of the manufacturing schedule.
  • Availability of necessary tools, supplies, equipment, and materials to complete work assignments.  This includes management of tools per approved procedures.

(Final Labeling):

  • Create and print finish product labels.
  • Verify finish good product labeling is completed according to product spec.
  • Confirmation of unit labeling completion per customer requirements.
  • Preparation of the finish good unit packaging and labelling.
  • Ensure compliance to quality system requirements for areas of responsibility.
  • Maintain records of applicable documentation.
  • Complete all transactions for Work Order Creation, Goods Issued, Good Receipt as required in SAP.
  • Participate in planning meetings as scheduled.
  • Place purchase requisitions for required supplies to maintain stock levels as needed.
  • Participate in systems upgrades, enhancements and implementations for supply and operations planning as required.
  • Review analyze and report on monthly transportation costs to ensure efficient use of transport lanes.
  • Record and monitor all items with shelf-life daily and notify appropriate personnel when material is pending expiration.
  • Prepare monthly reports for cycle count and pick-lists count for monthly highlights.

 

 

DIMENSIONS & LIMITS OF AUTHORITY

 

COMPANY

REQUIREMENTS

Must refer to relevant company handbook/policy statements detailing company procedures regarding employee conditions and benefits.

Authorisation of purchase orders is given in Authorisation of Limits produced by Finance Department

QUALITY

REQUIREMENTS

Ensure compliance with all quality systems regulatory requirements such as, but not limited to, ISO 13485, 21 CFR Part 820, MDSAP, MDD (93/42/EEC) and MDR (EU 2017/745)

Responsible for addressing issues within the QMS without undue delay as evidenced by on time completion of actions on the Single Action Tracker (SAT)

 

EH&S REQUIREMENTS

 

 

Create a safety culture and safe working environment.

Ensure compliance with all Environmental Health and Safety regulatory requirements.

Provide recourse to meet Environmental Health and Safety goals.

Maintain defined organisation Environmental Health and Safety competencies.

Ensure related Risk Assessments are completed, accidents raised and action hazards.

 

QUALIFICATIONS & EXPERIENCE

 

 

Minimum Skills and Capabilities:

  • Strong communication skills, both written and oral. Ability to complete professional, high-quality presentation, trending, research, and data compilation for communication with subordinates & management, etc. 
  • Strong management skills in the areas of control, accountability, delegation, planning, basic understanding of finances, organizational development, priorization, etc.
  • Strong judgement sills, ability to manage potential risks, understanding of organizational priorities and how to communicate these to subordinates.
  • Strong capability to implement systematic solutions to problems and performance objectives, Quality System requirements, human resource management issues, as well as a high degree of multi-tasking simultaneous priorities.

 

Minimum Knowledge & Experience required for the position:

  • BS in Science or Engineering or related field is helpful, however equivalent experience and training is applicable. 
  • Minimum 3-5 years’ experience in manufacturing environment as a supervisor.
  • Experience working in a highly regulated industry (e.g.: Medical Device, Pharmaceutical) is prefer.
  • Knowledge of quality system regulations (21CFR820 and ISO13485) and detailed knowledge of Manufacturing and Quality Instructions and related documentation within the area of responsibility.  Understanding of both basic QS requirements as well as higher level procedures (SOPs, etc.) relating to general operations compliance is a plus but not required.
  • Strong knowledge of manufacturing processes, understanding of basic material characteristics, process cause/effect knowledge, engineering drawings and schematics, as well as basic use of instruments and measurement techniques, tolerances, and maintenance of engineering notebooks for technical issues relating to production.
  • Develops effective technical objectives and executes technical approaches and timelines to meet or exceed them.
  • Teamwork to achieve a common goal.
  • Excellent leadership and communications skills with ability to organizationally collaborate effectively with others.
  • Bachelor’s degree in engineering/science and a minimum of ten years’ experience in the medical device industry or technical degree/certificate with appropriately equivalent technical experience in the medical device industry
  • Ability to organize and conduct experiments independently.
  • Ability to analyze and solve technical problems.
  • Good oral and written communication skills (English)
  • Hands on Experience building prototypes, tooling, test fixtures.
  • Working knowledge of plastics, metallurgy, and manufacturing processes
  • Use of SolidWorks, AutoCAD, or Pro-E as a design tool

 

 

It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.