Production Operator

Solesis•Franconia Township, PA

4h•Onsite

About The Position

The Production Operator supports multiple activities for manufacturing finished medical devices in compliance with applicable Quality System Regulations and Medical Device requirements. The Production Operator will primarily focus on manufacturing products and assembling and packaging final devices in ISO 7 cleanrooms. Additional key responsibilities are reporting on daily production counts, tracking scrap, and rejected material amounts, and assisting with inventory management.

Requirements

High School Diploma or equivalent
2 years prior experience in a regulated life science industry (e.g., Medical Device, Pharmaceutical) in one of the following functions: Quality Control or Manufacturing.
Must be able to detect defects occurring in products and packaging.
Operates test equipment, computer equipment, fax/copy machines, telephone, calculator, and general office equipment to generate input and output and transmit data.
Hands-on experience with manufacturing equipment such as packaging sealers, suture attaching machines, clicker press, laser cutter, hot knife, ultrasonic welder, etc.
Intermediate knowledge of MS Office Suite.
Good written communication skills.
Detail-oriented, self-starter with high attention to detail and ability to work with minimal instruction/supervision.

Responsibilities

Follows current good manufacturing process (cGMP) requirements, standard operating procedures, work instructions, test method, and customer specifications that follows the Quality Management System (QMS) to complete job requirements
Performs all duties required for manufacturing product and final device assembly
Performs all duties required for cleanroom packaging, labeling, and boxing operations
Perform in-process inspection such as qualitative and/or quantitative measurements required by work instructions and test methods
Records daily production activities and material counts in the production lot Device History Record and inventory management system
Reports production scrap and any nonconforming product on a daily basis
Assists with root cause analysis investigations when required
Ensures that production schedules are consistently met
Identifies and corrects product defects / production errors
Ensures the correct raw materials and components are issued to production and returned when production jobs are complete
Provides technical support for additional quality systems and functional areas as needed or assigned to, including, but not limited to, Training, Research & Development, Product & Process Development, Manufacturing and Quality Engineering, Preventive & Unscheduled Maintenance, Equipment Calibration and Process Validation
Authors documents, specifications, procedures, work instructions, validation protocol/reports, etc. as applicable.