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Assembly Operator - Hardware

JobRialto
Loveland, CO Full Time
POSTED ON 2/13/2025
AVAILABLE BEFORE 5/11/2025

Location : 4510 Byrd 4510 Byrd Loveland CO 80538 United States

Job Summary

Our company is seeking a highly motivated individual to join our Hardware Manufacturing Team. In this role, you will align, calibrate, and execute test methods of varying complexity according to operational plans and customer demand. We are looking for associates who thrive in a team-oriented, goal-focused environment. Our operations are driven by Daily Management principles, providing immediate guidance and feedback, and focusing on daily, monthly, and quarterly objectives. You will play an essential role in executing work orders, maintaining training records, and ensuring smooth material flow in a regulated and compliant manufacturing environment.

Key Responsibilities

  • Execution & Calibration : Align, calibrate, and execute test methods based on customer demand and operational plans.
  • Assembly & Supervision : Perform assembly tasks according to established Standard Operating Procedures (SOP) under supervision.
  • Troubleshooting & Compliance : Identify and troubleshoot issues during production, escalating as needed, while ensuring compliance with FDA Quality System Regulations (QSR), Good Manufacturing Practices (GMP), and ISO regulatory requirements.
  • Process Improvement : Proactively identify and recommend improvements in production methods, equipment performance, product quality, and efficiency.
  • Collaboration : Work directly and cooperatively with cross-functional team members to ensure a focus on quality and continuous improvement.
  • Training : Train new team members on equipment operations, work procedures, and safety protocols.
  • Documentation : Accurately complete production paperwork and maintain records of work orders and status.
  • Workplace Safety : Maintain a clean and safe working environment in compliance with company rules, regulations, and procedures.
  • Lean Manufacturing : Learn and actively participate in the company's lean manufacturing principles.

Required Qualifications

  • Education : High school diploma or equivalent.
  • Experience : Proficiency with Microsoft applications and ability to read, write, and speak fluent English to understand SOP / work instructions.
  • Technical Skills : Basic experience with hand tools is a plus for certain departments.
  • Regulatory Compliance : Familiarity with FDA QSR, GMP, and ISO requirements.
  • Communication Skills : Effective verbal and written communication with team members and leadership.
  • Physical Requirements : Ability to lift materials and equipment, maintain focus in a fast-paced environment, and comply with safety standards.
  • Teamwork : Ability to work collaboratively in a team-oriented environment and contribute towards team goals.
  • Preferred Qualifications

  • Experience : Previous experience in a manufacturing environment is preferred.
  • Industry Knowledge : Familiarity with medical device or reagent manufacturing is a plus.
  • Technical Skills : Experience with assembly line machinery or testing equipment is advantageous.
  • Certifications (if any)

    Lean Manufacturing certification or relevant training (preferred).

    ISO or FDA Compliance training certification is a plus.

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