Assembler III 3rd shift

Marquee Staffing; Irvine (CA); On-site; USD 37,000 - 40,000; Full time

Job summary

Marquee Staffing is seeking candidates for a contract-to-hire role in Irvine, CA. The position involves precision assembly of insulin pump implants in a cleanroom, using a microscope, with a strong emphasis on quality and safety.

Ideal candidates have 5 years of medical device production experience and familiarity with GMP/ISO and FDA regulations. Expect a 3rd shift on weekends (5:00am-5:30pm) with a pay range of $26.75–$28.89 per hour.

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.
• Wears personal protective equipment as required.

Responsibilities

• Support company goals and objectives, policies and procedures, GMP and FDA regulations.
• Comply with SOPs and DOPs, quality assurance program, safety and environmental standards.
• Establish, build and maintain professional relationships with staff, clients and suppliers.
• Read and interpret manufacturing procedures and graphics, ensure accuracy and deadlines.

Skills

Teamwork

Detail oriented

Communication

Job description

Contract to Hire $26.75/hr-$28.89 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

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.