Assembler II 3rd shift

Marquee Staffing; Irvine (CA); On-site; USD 32,000 - 34,000; Full time

Job summary

Marquee Staffing in Irvine is offering a contract-to-hire position with a medical device implant manufacturer. The role focuses on precision assembly of insulin pump implants in a cleanroom, requiring attention to detail and teamwork while using a microscope.

Ideal candidates have 3+ years in medical device production and experience in GMP/FDA/ISO environments, coupled with strong communication and meticulous accuracy. Weekend day shifts are included with a 3rd shift schedule.

Qualifications

• 3+ years related industry experience in medical device production assembly.
• 3+ 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.

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.

Skills

Precision assembly

Manufacturing experience

Attention to detail

Team player

Microscope in cleanroom

GMP/FDA compliance

Job description

Contract to Hire $23/hr-$25.14 3rd shift Weekend Day:5:00am-5:30pm

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

• 3+ years related industry experience in medical device production assembly.
• 3+ 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.