Lead Production Technician

SUMMARY

Lead Production Technician performs duties in all areas of operations to produce PTS products, using progressive skills and knowledge of the manufacturing process. This position requires the ability to document the manufacturing process to meet all standards for product safety, quality, and efficiency. In this position you are responsible for monitoring production to ensure that the device conforms to its specifications. This position will also ensure all Quality System Work Instructions (WI’s) are accurate and that their crew is trained on and following them when performing their job functions.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Ensure production area is safe to work in and has necessary inventories and tools to keep production running.
• Complete daily assigned tasks to meet production volume, quality levels, and schedule.
• Prepare and Assemble product according to established work instructions.
• Apply company policies and work instructions procedures to complete assignments.
• Treat peers and supervisors with respect.
• Be a team member in the assembly of PTS products.
• Other duties as assigned by Supervisor, Sr. Supervisor, or Production Manager
• Can Set-up, operate, and train others on ALL manufacturing equipment or work centers in their department.
• Manages the set-up, operation, and training of others in multiple complex manufacturing equipment with the Supervisor and Tech III.
• Conduct quality inspections on finished products and input materials for quality and adherence to PTS specifications.
• Masterfully understands their primary department but can work in other departments as directed by the supervisor.
• Prepare and verify materials to be used as issued to work orders.
• Takes ownership and provides considerable contributions to meet production goals and criteria for equipment yield and efficiencies to meet the production schedule.
• Understands the process flow between various process steps and can provide input on areas of improvement to increase efficiency. In charge of training and developing technicians to better understand the process flow.
• Has great investigation skills and executes basic troubleshooting on equipment and workstations before notifying maintenance or Teir III Technician.
• Manages progress of production metrics and takes action when an issue arises.
• Complete accurate production paperwork including start and end-run time, number of units produced, and total quantity completed, forms, work orders, batch records, and reports.

ESSENTIAL DUTIES AND RESPONSIBILITIES (cont.)

• Possess strong abilities to learn as well as being able to train and teach all employees.
• Effective verbal and written communication skills with Maintenance, Manufacturing Engineering, and Management to be able to accurately explain downtime problems/issues.
• Monitors all machines of their department and manages the resolution of problems.
• Oversees the completion of all in-process inspection of components and assemblies to verify quality conformance.
• Oversees the completion of cleaning and maintaining equipment and the work area as needed.
• Recognize any minor issues with the equipment and any affiliated documentation and take appropriate corrective action within scope.
• Demonstrates dedication and flexibility to ensure production runs smoothly.
• Possess the ability to effectively type e-mails, QT9 items, work instruction updates, and other various items as needed by supervisor.
• Provide continuous leadership while working in a team environment.
• Report causes of process and/or documentation and assist or coordinate resolutions.
• Leads shift changes, lot changes, and start-ups.

QUALIFICATIONS

• Ability to lift approximately 25lbs.
• This position may require irregular and extended hours of work, so the person hired must be capable of meeting the varied work hours.
• Understands Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP)
• Must be a team player and leader.
• Ability to clearly and effectively communicate with peers, supervisors, and managers.
• Effective verbal and written communication skills
• Ability to pay close attention to detail.
• Basic Computer Skills
• Ability to solve basic math problems

EDUCATION and/or EXPERIENCE

• High school diploma or general education degree (GED).
• One to two years related experience in Manufacturing in the medical device, pharmaceutical or biotech industry, or equivalent combination of education and experience.
• Experience managing or leading a team.
• Experience in an FDA regulated environment is preferred.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. While performing the duties of this job, the employee is regularly required to use hands to touch, manipulate, handle, or feel production items or materials repetitively. The employee frequently is required to stand and/or sit for extended periods of time. The employee is required to reach with hands and arms. Specific vision abilities required by this job include close vision. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Lab coat, safety glasses, hair nets, gloves, and other PPE are required in production rooms based on the function and task. Most production rooms are kept at a controlled temperature and humidity for assembly of PTS products.

EQUAL OPPORTUNITY EMPLOYER

PTS Diagnostics is an Equal Opportunity and E-Verify employer. Employment decisions for all applicants and employees will be made without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, age, national origin, marital status, veteran status, disability, or other characteristics protected under local, state, or federal law.

QUALITY COMMITMENT

This position requires compliance to applicable quality system and regulatory requirements. This individual adopts a “quality in everything we do” approach to all aspects of the execution of responsibilities of this position. Through vigilance, this individual remains alert to any potential compliance situations, and must report such observations to managers and the Head of Quality.

STATEMENT of OTHER DUTIES DISCLAIMER

This job description in no way states or implies that these are the only duties to be performed by this employee. This employee will be required to follow any other instructions and to perform any other duties requested by their supervisor.