Assembler

Assembler Position

The Assembler position requires the employee to learn how to safely assemble, manufacture, and package regulated medical devices and kits in a performance driven environment under the supervision of higher-level operators / Supervisors / Managers. The employee will work to understand and meet all quality standards and adhere to all cGMP standards.

Key Duties

Major Duties and Responsibilities

• Maintain a safe work environment by complying with all safety and environmental policies including the use of PPE.
• Expand upon limited knowledge of departmental operations to understand the equipment and processes.
• Perform manual and automated assembly/packaging of diagnostic kits & sensors.
• Read, understand, and comply with current Good Manufacturing Practices and Standard Operating Procedures.
• Learn to operate automated production equipment with direct supervision of a trained operator or higher.
• Complete daily documentation required for production procedures and supplemental documentation as needed.
• Audit own paperwork for corrections, missing, and/or incomplete information ensuring that it is neat, accurate, and legible, following GDP practices.
• Comply with all OSHA, FDA, ISO, Quality system, Company and departmental requirements.
• Learn to perform calibrations and routine process monitoring as needed.
• Conduct in process sampling and/or inspections and document per procedure.
• Notify supervisor of any manufacturing material that may be running low.
• Identify and communicate any / all abnormal components and deviating events to the Group Leader/Supervisor/Manager.
• Learn to use necessary computer programs for the required job tasks and managing job benefits, such as time & attendance.
• Demonstrate willingness to work with other departments and employees as required and accept instruction from higher level positions.
• Operator or higher-level employee attention is required at this level.
• Other duties as required.
• Must be able to demonstrate cross-training ability as set forth by management.

Job-Specific Responsibilities (but not limited to):

Kit Assembly

• Perform related duties, under general supervision, following clearly prescribed standard practices
• Operate shrink wrapper machine to wrap packages to obtain proper wrapping.
• Perform inventory checks and pick parts from stock room for kitting operations according to job order.
• Confirm lot number on each job with Quality Control, and process paperwork on each order/lot
• Inspect reagent tubes, capillaries, droppers, buttons and other associated kit components for shipments.
• Assemble kits under supervision of operators or manager.
• Under supervision of higher level operators run or assist in running automated equipment to produce kit components.

Sensor Assembly

• Label vials, take inventories, keep records, and perform related duties under general supervision, following clearly prescribed standard practices.
• Assemble product in accordance with written specifications and procedures, ensuring lot number conformity and other quality requirements are satisfied.
• Move boxes of product in area, stock shelves with specified items, take inventories of all items in storage area and keep related records.
• Confirm lot number on each job with Quality Control and process paperwork on each order/lot.
• Provide Quality Control with samples of products for appropriate testing, etc.

Analyzer Assembly & Test

• Complete all required documentation following GDP guidelines.
• Perform a variety of assembly operations associated with instrument production, which include hand assembly of components onto printed circuit boards.
• Perform critical cleaning procedures, mixing and injecting epoxy and testing equipment used in instrument production.
• Able to follow direction of senior operators in work cell for instruction.

Other Duties/Physical Requirements

• Must have the ability to inspect, analyze and concentrate throughout the course of the work shift.
• Must be able to concentrate and problem solve routinely throughout the course of the work shift.
• Must have fine manual dexterity to ensure precise assembly of medical devices.
• Must have the ability to lift up to 25 pounds of supplies or finished product throughout the work shift.
• Ability to stand and/or sit for long periods, stoop, reach, bend, push and pull carts and hand jacks throughout the course of the work shift.
• Ability to wear all required personal protective equipment (lab coat, safety glasses, hair coverings, latex or nitrile gloves)
• Must be able to identify and differentiate color and color changes on diagnostic devices and device components.
• Must be able to read, navigate, and operate controls systems screens and written documents throughout the course of the workday.
• Must be able to detect audible and or visual alarms.

Qualifications

Minimum Education or Equivalent Experience Required/Preferred:

• High School Diploma or general education degree (GED) preferred.
• Prior manufacturing and/or assembly experience preferred.
• Prior experience in an FDA regulated production environment preferred.

Competencies Required or Preferred:

• Learn and retain good documentation practices.
• Computer literacy / skills required (e-mail and Windows).
• Must have basic math skills and be able to perform step by step arithmetic calculations.
• Must show initiative, have critical attention to detail, and be organized.
• Develop interpersonal, organizational, written, comprehension, and oral communications skills.
• Ability to maintain regular attendance and punctuality requirements.
• Must be able to work overtime and weekends to support production efforts as needed.
• Develop problem solving and troubleshooting skills.

Required Travel%

• None

*All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. (USA Only)