Assembler I 1st Shift

Marquee Staffing; Irvine (CA); On-site; USD 26,174 - 27,552; Full time

Job summary

Marquee Staffing in Irvine, CA is seeking candidates for a contract-to-hire role in precision assembly of insulin pump implants in a cleanroom environment, utilizing a microscope. The position emphasizes attention to detail, teamwork, and adherence to established procedures.

Applicants should be comfortable reading engineering drawings and manufacturing procedures and must comply with GMP/ISO standards, SOPs, and safety regulations while delivering high-quality results on schedule.

Qualifications

• Experience in FDA/GMP/ISO environment preferred
• Excellent interpersonal, verbal, and written communication
• Meticulous attention to detail and safety awareness

Responsibilities

• Support company goals and objectives, policies and procedures, GMPs, FDA regulations including ISO 13485 compliance.
• Build and maintain professional relationships with staff, clients and suppliers.
• Exhibit strong interpersonal, verbal and written communication skills.
• Demonstrate meticulous attention to detail and meet deadlines.
• Learn new equipment and processes and quickly achieve proficiency.
• Read and interpret manufacturing procedures, engineering drawings and inspection procedures; ensure compliance with requirements.
• Practice and advocate good safety skills.

Skills

Attention to detail

Teamwork

Communication

Read drawings/Procedures

Tools

Microscope operation

Job description

Contract to Hire $19 - $20/hr Shifts: 1st shift Monday - Thursday 5:00am - 3:30pm

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

• Experience in FDA/GMP/ISO environment preferred
• Excellent interpersonal, verbal, and written communication skills.
• Meticulous attention to detail Wears personal protective equipment as required.