Quality Inspector

RecruitGigs; Palo Alto (CA); On-site; USD 80,000 - 100,000; Full time

Job summary

A well-established medical device manufacturer is seeking a Senior Quality Inspector in Palo Alto, CA. Responsibilities include performing complex inspections of medical device components to ensure compliance with quality standards. Candidates need 5+ years of inspection experience, strong knowledge of ISO 13485 and FDA regulations, and proficiency in various inspection tools. This role supports corrective actions and requires attention to detail and skills in documentation. A collaborative team environment awaits the right professional.

Qualifications

• 5+ years of quality inspection experience in medical devices.
• Strong knowledge of ISO 13485 and FDA quality systems.
• Proficient in reading engineering drawings and GD&T.
• Experience with inspection tools.

Responsibilities

• Perform detailed inspection of precision components.
• Conduct first article inspections and document results.
• Ensure compliance with ISO and FDA standards.
• Train and mentor junior inspectors as needed.

Skills

Quality inspection experience

Attention to detail

Problem-solving ability

Documentation skills

Education

Associate’s degree or technical certification in Quality or related field

Tools

Calipers

Micrometers

Height gauges

CMM

Job description

Our client is a well-established and growing medical device manufacturer located in Palo Alto, CA. They are committed to producing high-quality, precision-engineered products that meet strict regulatory and customer requirements. This is an excellent opportunity to join a collaborative team in a fast-paced, highly regulated environment.

Position Summary

The Senior Quality Inspector is responsible for performing complex inspections of incoming, in-process, and finished medical device components to ensure compliance with internal specifications, customer requirements, and regulatory standards. This role requires strong technical inspection skills, attention to detail, and experience working within FDA-regulated environments.

Key Responsibilities

• Perform detailed inspection of precision components and assemblies using hand tools and advanced measuring equipment
• Interpret engineering drawings, GD&T, blueprints, and specifications
• Conduct first article inspections (FAI) and document results
• Perform incoming, in-process, and final inspections
• Ensure compliance with quality system requirements (ISO and FDA standards)
• Identify nonconforming materials and assist with root cause investigations
• Support corrective and preventive action (CAPA) activities
• Maintain accurate inspection records and documentation
• Train and mentor junior inspectors as needed
• Collaborate with engineering, manufacturing, and quality teams to resolve quality issues

Qualifications

• 5+ years of quality inspection experience in medical device or regulated manufacturing
• Strong knowledge of ISO 13485 and FDA quality system regulations
• Proficient in reading engineering drawings and GD&T
• Experience with calipers, micrometers, height gauges, comparators, CMM, and other inspection tools
• Experience performing First Article Inspections (AS9102 experience is a plus)
• Strong documentation and organizational skills
• High attention to detail and problem-solving ability

Preferred Qualifications

• Associate’s degree or technical certification in Quality, Manufacturing, or related field
• Experience in cleanroom environments
• Prior experience mentoring or leading inspection teams