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Medical Device Assembly Technician

2 months ago

Morrisville, North Carolina, United States Advantage Technical Full time
Job Description

Primary Responsibilities:

  • Assemble, clean, and package Single-Use assemblies according to Engineering Process Records (EPR), drawings, and Standard Operating Procedures (SOP).
  • Utilize appropriate personal protective equipment (PPEs) and report all near-miss incidents and first aid events.
  • Adhere to cleanroom protocols and current Good Manufacturing Practices (cGMPs) to sustain an ISO Class 7 environment.
  • Engage actively in continuous improvement initiatives and adhere to change control procedures.
  • Identify and escalate potential process or product deviations to minimize scrap, rework, and customer returns.
  • Maintain daily organization (6S) and cleanliness of individual and common work areas.
  • Contribute to inventory accuracy by correctly returning unused parts and components to stock, ensuring they are sealed with part numbers and lot traceability.
  • Comply with ISO 9001:2015 quality standards in all manufacturing processes in line with company quality objectives.
  • Meet internal production schedules to ensure on-time delivery.
  • Complete and sign off on EPRs for each assembly operation performed.
  • Ensure assemblies are completed within the designated time frame as specified on the work order.
  • Foster a do it right the first time mindset.
  • Perform additional duties as assigned.
Qualifications:

Minimum Requirements:

  • High School Diploma or equivalent (GED)
  • 0-2 years of experience in a cleanroom production environment

Preferred Qualifications:

  • Prior experience in a cleanroom setting
  • Ability to interpret engineering drawings