Assembler III 2nd shift

Marquee Staffing; Irvine (CA); On-site; USD 36,000 - 39,000; Full time

Job summary

Marquee Staffing is partnering with a medical device implant manufacturer in Irvine to fill a Contract to Hire role focused on precision assembly using a microscope in a cleanroom environment.

Requires 5 years in medical device production, FDA/GMP/ISO experience, meticulous attention to detail, teamwork, and strong communication; PPE is required. Second shift: Mon-Thu, 3:30 PM–2:00 AM; on-site; competitive pay with potential for permanent hire.

Qualifications

• 5 years related industry experience in medical device production assembly.
• Experience in FDA/GMP/ISO environment preferred.
• Excellent interpersonal, verbal, and written communication skills.
• Meticulous attention to detail.
• Wears personal protective equipment as required.
• Read and interpret manufacturing procedures, engineering drawings, and inspection procedures.

Responsibilities

• Support company goals and objectives, policies and procedures, GMP and FDA regulations.
• Comply with SOPs and DOPs, quality assurance program, and safety standards.
• Establish and maintain professional relationships with staff, clients, and suppliers.
• Demonstrate accuracy and thoroughness; monitor own work to ensure quality.
• Practice and advocate good safety skills.

Skills

Attention to detail

Teamwork

Excellent communication

Reading engineering drawings

Microscope operation

Tools

Microscope

Job description

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.