Quality Inspector II - Medical Devices (Swing Shift)

BioRobotics; San Jose (CA); On-site; USD 41,328 - 48,216; Full time

Job summary

PROCEPT BioRobotics is seeking a Swing IQC Inspector II in California to lead incoming inspections of materials and subassemblies for the Aquabeam Robotic System. You will ensure compliance with drawings and sampling plans, escalating nonconformances and supporting containment activities.

The role requires 3+ years in manufacturing quality inspection, familiarity with ISO 13485 and GDP, and proficiency with calipers, micrometers, height gauges, and vision systems.

Qualifications

• Minimum 3 years of quality inspection experience in a manufacturing environment, preferably medical device.
• Experience interpreting engineering drawings, specifications, and inspection requirements.
• Basic knowledge of ISO 13485:2016 and Good Documentation Practices (GDP).
• Experience using measurement instruments, including calipers, micrometers, height gauges, vision system, microscopes, and related inspection tools.
• Experience with sampling plans and AQL inspection methods.
• Ability to work with minimal supervision.

Responsibilities

• Perform incoming inspections of raw materials, components, subassemblies, and finished goods in accordance with approved procedures, engineering drawings, specifications, and sampling plans.
• Identify, document, and escalate nonconforming materials. Initiate Nonconforming Material Reports (NCMRs) as required.
• Support containment activities, material segregation, and investigations related to supplier and incoming quality issues.
• Maintain Incoming inspection files according to PROCEPT’s procedures
• Maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and regulatory compliance.
• Update job knowledge by studying trends and developments in quality management, participating in educational opportunities, reading professional publications, and maintaining professional networks.
• Understand and adhere to PROCEPT BioRobotics Quality and Environmental Health & Safety (EHS) policies.

Skills

Quality inspection

Reading drawings

GDP knowledge

Measurement tools

AQL sampling

Communication

Documentation

Tools

Calipers

Micrometers

Height gauges

Vision system

Microscopes

Job description

PROCEPT BioRobotics is seeking a Swing IQC Inspector II in California to lead incoming inspections of materials and subassemblies for the Aquabeam Robotic System. You will ensure compliance with drawings and sampling plans, escalating nonconformances and supporting containment activities.

The role requires 3+ years in manufacturing quality inspection, familiarity with ISO 13485 and GDP, and proficiency with calipers, micrometers, height gauges, and vision systems.