Enable Injections Hiring for Manufacturing Assembly Technician atCincinnati, OH Full Time

PURPOSE OF POSITION: This position is responsible for directly assembling product for Enable Injections. Typical tasks will include assembling of small parts; use of machines such as heat stakers, ultrasonic welders, and tray sealers; packaging of product; and inspection of manufacturing steps. This position requires individuals to read and understand documented procedures and fully demonstrate the ability to consistently follow those procedures. This role also requires that individuals document their work following Good Documentation Practices. The Manufacturing Assembly Technician I will also be responsible for maintaining the cleanliness of the clean room environment which will require periodic cleaning of floors, tables, equipment, and storage containers.

QUALIFICATIONS:

Required:

• Position requires High School diploma or GED
• Ability to read and write fluently in English
• Must be a detail-oriented individual who is highly organized and willing to work in a fast paced and constantly evolving environment
• Must have excellent interpersonal skills and be able to consistently demonstrate a high degree of professional maturity
• Ability to maintain regular attendance and punctuality requirements
• Willingness and ability to work overtime as needed on both weekdays and weekends
• Must be able to work independently as well as collaboratively with team members as needed

Preferred:

• Production/manufacturing experience is highly preferred, specifically with the precise assembly of small components
• Experience working in a regulated FDA, or other government agency, environment
• Prior experience with GMPs and/or sanitation SOPs
• Prior experience with International System of Units (metric system)

Skills & Competencies:

• Basic computer skills (Outlook, web browsers)
• Ability to read and understand all company procedures and policies
• Ability to perform basic arithmetic
• Ability to take direction from supervisors and collectively work with others in a team environment
• Desire to work in a constantly changing, dynamic work environment.

  The production schedule is more dynamic than a standard assembly line position

• Required to work in a Clean Room (ISO Class 8 or higher) during the entire shift and maintain high standards of personal hygiene
• Ability to work with small parts, using magnification or other visual aids
• Working with small parts that require repetitive motion in the execution of tasks
• Wear clean room gowns, hair nets, gloves, safety glasses, and shoe covers for extended periods of time
• Ability to read Quality System Procedures, Operating Procedures, and Inspection Requirements, and demonstrate the execution of tasks to meet Enable Injections Quality System requirements
• Ability to follow Good Documentation Practices to complete documentation in English as needed to record work or inspection data
• Ability to operate mechanical machinery and inspection equipment
• Ability to work in a highly regulated industry where the execution of tasks has a direct patient impact
• Ability to work as an individual in a team environment where all Technicians are responsible for the quality of finished devices

Physical Requirements:

• Ability to work with small parts, using magnification or other visual aids
• Working with small parts that require repetitive motion in the execution of tasks
• Wear clean room gowns, hair nets, gloves, safety glasses, and shoe covers for extended periods of time
• Ability to read Quality System Procedures, Operating Procedures, and Inspection Requirements, and demonstrate the execution of tasks to meet Enable Injections Quality System requirements
• Ability to operate mechanical machinery and inspection equipment
• Ability to sit and stand for an extended period

RESPONSIBILITIES

• Assembly and packaging of medical products in accordance with documented procedures
• Maintaining a high level of quality in the execution of all tasks. If quality issues arise, Manufacturing Technicians are required to notify Enable Injections production supervision and/or management immediately.
• Assisting manufacturing and quality assurance with the formal and informal inspection of components, subassemblies, and finished devices while executing tasks
• Adherence to Controlled Environment practices.This includes actively monitoring ones compliance as well as ensuring anyone in the clean room space is also in compliance.
• Performing general cleaning activities for Controlled Environment in accordance with established procedures
• Understanding and executing the Enable Injections Quality Policy and training requirements as they pertain to this job description
• Assisting production management with other manufacturing related activities which include organizing materials, loading boxes, counting and recording materials, completing documentation
• Other tasks as required by production management, including but not limited to: assembly of tables and other furniture or equipment for manufacturing purposes, cleaning of surrounding manufacturing areas including the warehouse and hallways, etc.

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