Excelsior Medical Corporation Job Description

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Job Title: Manufacturing Manager

Reports To: Director of Manufacturing

SUMMARY:  Plans, coordinates and manages the production/manufacturing process of existing and new products and its production lines ensuring that Quality Systems procedures, FDA, ISO:13485:2003, and CMDCAS regulations are followed.  Incumbent will lead the team of Production Supervisors responsible for multiple manufacturing disciplines.  Position also supports product development initiatives.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following (other duties may be assigned):

• Supervise all shifts in the filling, tray filling and sterilization operations on a daily basis.
• Ensure that all products manufactured meet established product specifications by enforcing internal procedures and cGMP standards as required by the Quality Systems regulations – CFR 820 and ISO 13485:2003.
• Actively participate in the preparation, management and control of the manufacturing budget.
• In conjunction with Customer Service and Production Planning, create working schedules for all manufacturing activities in the filling, tray filling and sterilization areas.
• Responsible for CAPAs, deviations, NCMRs and change controls related to the filling, tray filling and sterilization areas.
• Continue development and leadership of a strong lean manufacturing strategy to continuously improve efficiencies and reduce product cost.
• Constantly strive to eliminate sources of waste including syringe rejects and non-value added activities. 
• Report and generate new cost reduction ideas and implement them whenever possible.
• Direct, train, evaluate and discipline manufacturing employees to ensure a highly qualified work force.
• Establish performance goals and conduct performance appraisals.
• Implement and enforce productivity standards and policies and procedures.
• Support South America new product development activities ensuring that all manufacturing requirements are fulfilled during the design control process.
• Quickly resolve any operational problems including employee complaints ensuring excellent employee/employer relations.
• Effectively allocate resources and time across teams and manufacturing departments.
• Plan, organize, direct and control workflow and employee activities with the assistance of Production Supervisors.
• Provide daily, weekly and monthly reports to the Senior Management team as required.

QUALIFICATION REQUIREMENTS:  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE:

              Bachelors in Engineering /Business

Minimum 5 years manufacturing and/or production experience with MD/Pharmaceutical companies

Broad manufacturing background with problem solving, project management and supervisory skills.

Experience with FDA regulations and requirements for medical device manufacturers.

              LANGUAGE SKILLS:

              Must be Bilingual (Spanish/English).

              Excellent written and verbal communication skills required.

              REASONING ABILITY:

Planning, making logical decisions, problem solving, analytics, and implementing solutions.

              CERTIFICATE, LICENSES, REGISTRATIONS:

Education documentation is required. Any other licenses or certifications are to be provided at the discretion of the candidate.

              OTHER SKILLS and ABILITIES:

Position requires incumbent to be a team leader and a team builder.

              Mechanically inclined.

              Strong attention to detail and organizational skills.

              Project Management skills

              Ability to multitask.

              Excellent verbal and written communication skills

              Strong interpersonal and management skills

Computer literate and proficient in:  Microsoft Office – Outlook, Word, Excel and PowerPoint

PHYSICAL DEMANDS:  The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Job requires employee to stand, walk, talk, provide training to individuals or groups and do presentations for upper management.
• Job requires employee to spent at least 40 % of his/her time working on the computer.
• Manufacturing floor environment.

WORK ENVIRONMENT:   The work environment characteristics described here are representative of those an employee encounters while performing essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Employee occasionally works near machinery.

• Noise level in the manufacturing work environment may become on occasions loud.  Noise level in the office work environment is usually quiet.
• Working environment is dynamic and as a result can be stressful for some people.

Accepted by: _____________________________________

Print Name: ______________________________________

Date: ___________________________________________  

Approved by: _____________________________________

Print Name: ______________________________________

Date: ___________________________________________