Medical Device implant manufacturer in Irvine is seeking applicants with manufacturing experience to join their team! 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 in a cleanroom environment.
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.
Demonstrate accuracy, thoroughness and monitors own work to ensure quality.
Practice and always advocate good safety skills.
Education and Experience
High School Diploma, GED, or equivalent required
Minimum 6 months of recent manufacturing experience required, medical device manufacturing experience preferred
Experience in FDA/GMP/ISO environment preferred
Excellent interpersonal, verbal, and written communication skills. Meticulous attention to detail
2+ years of experience in a medical device environment ideally preferred.
Work Environment
Works in a Lab, Clean Room, and Warehouse environment, within a well-lighted work area with good ventilation and normal noise levels from lab, shop equipment, and clean room.
Sitting or standing at a production workstation with frequent walking to transact product; intermittently write or use a keyboard to communicate through written means.
Physical Demands
While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to handle or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear.
Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus. Employee must occasionally lift and/or move up to 40 pounds.
Required to wear personal protective equipment as required.
Numbers & Facts
Location
Irvine, CA
Salary
$20.33–$23
Skills
Cleanroomunmatched
Communication Skillsunmatched
Computer Workstationsunmatched
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
Interpersonal Skillsunmatched
Keyboardsunmatched
Laboratory Equipmentunmatched
Lift/Move 40 Poundsunmatched
Manufacturingunmatched
Medical Equipmentunmatched
Physical Demandsunmatched
Presentation/Verbal Skillsunmatched
Quality Assuranceunmatched
Quality Metricsunmatched
Regulatory Complianceunmatched
Safety Standardsunmatched
Standard Operating Procedures (SOP)unmatched
Time Managementunmatched
Warehousingunmatched
Writing Skillsunmatched
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