Contract to Hire $26.25/hr-$28.35 2nd shift Monday - Thursday: 3:30 PM 2:00 AM Summary/Objective:
Medical Device implant manufacturer in Irvine is seeking applicants with manufacturing experience to join their team! Facilitating the manufacturing of insulin pump implants, this position will primarily perform precision assembly requiring, attention to detail, initiative, working well within a team, and ability to produce consistently high-quality results while using a microscope in a cleanroom environment. Essential Duties and Responsibilities
Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations including compliance to EN ISO 13485, Medical Device Quality Standards.
Comply with company Standard Operating Procedures (SOPs) and departmental policies and procedures (DOPs), objectives, the quality assurance program, as well as safety and environmental standards. Ability to establish, build and maintain professional working relationships with all levels of staff, clients, and suppliers.
Excellent interpersonal, verbal, and written communication skills. Meticulous attention to detail and meeting deadlines.
Ability to learn new equipment and processes, and quickly demonstrate proficiency in their operation.
Read and interpret manufacturing procedures, engineering drawings, and inspection procedures and comply with their requirements. All documents are written in English.
Demonstrates accuracy, thoroughness and monitors own work to ensure quality.
Practice and always advocate good safety skills.
Education and Experience
5 years related industry experience in medical device production assembly.
5 years of experience in a medical device environment
Experience in FDA/GMP/ISO environment preferred
Excellent interpersonal, verbal, and written communication skills. Meticulous attention to detail
Wears personal protective equipment as required.
Numbers & Facts
Location
Irvine, CA
Salary
$26.25–$28.35
Skills
Cleanroomunmatched
Communication Skillsunmatched
Detail Orientedunmatched
Engineering Drawingunmatched
English Languageunmatched
FDA (Food and Drug Administration)unmatched
FDA Requirementsunmatched
GMP (Good Manufacturing Practices)unmatched
Healthcare Qualityunmatched
ISO (International Organization for Standardization)unmatched
Implantsunmatched
Insulinunmatched
Interpersonal Skillsunmatched
Manufacturingunmatched
Manufacturing Assemblyunmatched
Medical Equipmentunmatched
Presentation/Verbal Skillsunmatched
Pumpsunmatched
Quality Assuranceunmatched
Quality Metricsunmatched
Regulatory Complianceunmatched
Safety Standardsunmatched
Standard Operating Procedures (SOP)unmatched
Time Managementunmatched
Writing Skillsunmatched
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