Production Assembler
Description

JOB DESCRIPTION

Job Title:

Production Assembler

Management Approval: Print Name/Job Title

Laura Sabo, Global Vice President of Quality, Regulatory Affairs and Supply Chain

Department:

Production

Signature/Date

Exemption Status:

Non-exempt

HR Approval: Print Name/Job Title

Joanne Woolfall, Global Sr. Vice President, Human Resources

Pay Grade:

Signature/Date

TBD

This version supersedes all prior versions

Job Summary

Reporting to the Production Supervisor, the Production Assembler will be responsible for producing medical supplies or devices by assembling parts and subassemblies.

Essential Job Functions

  • Completes training to stay current with job and procedural requirements
  • Documents all work related activities by completing the appropriate Production and Quality forms
  • Performs and documents scheduled cleaning of production areas per procedure; performs and documents line clearance before each production run per procedure
  • Prepares work to be assembled by studying assembly instructions, drawings, and bill of material lists, gathering components, subassemblies, tools, and materials
  • Positions, assembles, and seals device components in accordance with work and batch record instructions
  • Verifies specification requirement by measuring completed components or through comparison of components to a visual aid, as appropriate
  • Resolves assembly problems by adjusting dimensions to meet specifications; notifying supervisor to obtain additional resources, when required
  • Keeps equipment operational by following manufacturer's instructions; troubleshooting malfunctions; calling for repairs and documenting all preventative maintenance (PM) and repair activities
  • Maintains safe and clean working environment by complying with procedures, rules, and regulations
  • Maintains component inventory for production orders, by checking stock to determine inventory level; anticipating needed materials; placing and expediting orders for components and subassemblies; verifying receipt of components and materials
  • Conserves resources by using equipment and materials as needed to package quality medical products and deliver on time
  • Contributes to team effort by completing assigned tasks in the time required
  • Perform work according to GMP and ISO guidelines

Qualifications

  • High School diploma or GED
  • Excellent manual dexterity
  • Able to follow instructions
  • Standing or sitting gowned for the majority of workday
  • Attention to detail, strong analytical and organizational skills
  • Must be able to assemble various products
  • Strong work ethic and understanding of basic Quality systems
  • Able to read and interpret documents such as safety rules, standard operating procedures, work process aids, company policies, and instruction manuals
  • Able to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals
  • Able to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form
  • Able to speak, read and write English fluently
  • Must haves: positive attitude, dependable, team oriented and hard-working

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the responsibilities of the supervisor’s job, the employee is required to talk and hear. The employee is often required to sit and use his or her hands and fingers, to handle or feel. The employee is occasionally required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision.

Mental Requirements

This position requires the ability to maintain an appropriate work pace, comprehend and follow instructions. The employee is required to exercise logic and reasoning; organize and prioritize; read; compose written communication; communicate verbally; make decisions; count and compute; analyze and interpret data; multi-task/re-direct; experience numerous interruptions. This position requires the ability to maintain the highest standards of professional maturity and emotional intelligence even in difficult or stressful situations.

Other Requirements

The employee must be trained on all of the documents, procedures, software applications and topics outlined by Quality Assurance. Documentation of this training will be maintained with Human Resources. Additional training requirements may be added as deemed necessary by the manager

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts and vehicles. The noise level in the work environment is usually quiet to moderate.

This job description is not designed to cover an exhaustive list of duties. Other duties may be assigned and activities may change at any time with or without notice.

Employee Print Name: _______________________________________________________________________________

Signature: _____________________________________________________________________ Date: _______________