Mfg Indirect - Assembly Combo - Production Lead

Viant•Vega Baja, PR

2d•Onsite

About The Position

The Production Leader performs assigned duties at combo assembly stations to ensure products comply with specifications. The role includes completing production reports and production transactions in the ERP system at the end of the shift, along with other ERP-related requirements. If the employee is absent, another trained Combo Assembly lead assumes the duties. The employee follows all Good Manufacturing Practices (GMP) rules and procedures outlined in the training program. The position is based at Viant Puerto Rico, which supports sterile and non-sterile medical devices through drug delivery and complex device assembly.

Requirements

Bachelor of Science in Engineering, Business Administration, Technology, or Computer-related field.
One year of experience in the manufacturing industry, preferably medical-device related, or in the pharmaceutical industry.
Knowledge or skills in process improvement, root cause analysis (RCA), Failure Mode and Effects Analysis (FMEA), Statistical Process Control (SPC), Lean Manufacturing, Six Sigma methodologies, quality systems (ISO 9001, AS9100, GMP), data analysis and reporting, IQMS, technical documentation, MasterControl, risk assessment, equipment validation and qualification, and manufacturing process optimization.
Regularly stand, walk, stop, kneel, crouch, and use hands to finger, handle, or feel objects.
Frequently move and/or lift objects up to 50 pounds.
Have close, distance, color, peripheral, and depth vision.
Wear company-approved safety glasses in the manufacturing area.

Responsibilities

Work daily in the assigned combo assembly area.
Understand and follow Good Manufacturing Process (GMP) procedures.
Execute reports and dispositions in the ERP system.
Understand and follow One Piece Flow and 5S systems.
Understand and run the Kanban system for inventory parts in the combo assembly area, as required.
Ensure production complies with quality specifications and notify supervisors of product problems.
Ensure product is packaged correctly.
Complete paperwork related to combo assembly assignments, including auxiliary equipment data, as required.
Perform other work-related duties assigned by the supervisor.
Follow safety policies and procedures.
Be flexible regarding possible schedule extensions.
Live Viant core values.
Support the validation process for New Product Development.