Medical Device Assembler II – Cleanroom GMP Specialist

Endologix; Santa Rosa (CA); On-site; USD 30,000 - 34,000; Full time

Benefits offered by this job

Competitive pay

Solid benefits

Career growth opportunities

Culture that cares

Job summary

Endologix LLC in Santa Rosa, CA—a federal contractor—seeks a Manufacturing Associate II to join our mission-driven team assembling high-quality medical devices per approved processes. You will help resolve line issues, contribute to process improvements, and ensure GMP and GDP compliance in a cleanroom environment.

Ideal candidates have 2–4 years in medical device manufacturing or regulated life sciences, experience handling microscopes and precision tools, and a track record of quality, safety,

Qualifications

• Must have 2–4 years in medical device manufacturing or regulated life sciences.
• Experience in cleanroom environments and aseptic technique.
• Experience with manual assembly under a microscope.
• Familiarity with FDA, ISO 13485, and GMP regulations.

Responsibilities

• Follow safety guidelines and company policies for a safe workplace.
• Assemble products using hand tools, microscopes, and fixtures with precision.
• Identify and communicate safety/quality concerns promptly.
• Maintain cleanroom attire and procedures to protect product quality.
• Perform in-process quality checks and provide timely feedback.
• Document nonconforming materials and ensure proper follow-up.
• Take ownership of work quality and maintain accurate quality records.
• Comply with GMP and GDP in all documentation.
• Collaborate with supervisors, engineers, and technicians to resolve line issues.
• Engage in lean and 5S initiatives to improve production.

Skills

GMP knowledge

Attention to detail

Team collaboration

Good documentation

Education

High school diploma or GED

Associate degree preferred

Tools

MS Office

ERP/MES systems

Job description

Endologix LLC in Santa Rosa, CA—a federal contractor—seeks a Manufacturing Associate II to join our mission-driven team assembling high-quality medical devices per approved processes. You will help resolve line issues, contribute to process improvements, and ensure GMP and GDP compliance in a cleanroom environment.

Ideal candidates have 2–4 years in medical device manufacturing or regulated life sciences, experience handling microscopes and precision tools, and a track record of quality, safety,