QC Inspector II, In-Process & Finished Product (2nd Shift)

About the role

Terumo Neuro is hiring an Inspector II for in-process and finished product quality control on the 2nd shift in Aliso Viejo, California. The role covers quality control inspections of products from sub-assemblies to final assemblies, and supports the QC Lead in reviewing device history records to assure compliance.

Key responsibilities

• Perform visual and dimensional QC inspection and testing of incoming materials, in-process materials, sub-assemblies, labeling and finished goods using visual inspection systems and other tools.
• Accurately measure and record data on data collection forms, read product drawings and specifications, and input data into online tracking software.
• Review in-process batch documentation in real time against product specifications, GDDP, SOPs and cGMPs, and coordinate calibration of equipment and tools.
• Coordinate with production associates on in-process, finished product and final documentation reviews to release goods, and help the QC Lead close and upload build records.
• Record and communicate nonconformances so corrective actions are completed on time, and give feedback to Quality and Manufacturing on quality issues.
• Maintain a safe, clean workplace following 5S principles, train other inspectors on QSs, TMs and procedures, and work overtime when needed.

Required profile

• High school diploma or equivalent.
• At least 3 years of relevant experience in medical device manufacturing or inspection.
• Ability to work in a fast-paced environment, balance priorities to support production schedules, and work with a culturally diverse team.
• Physical demands: extended periods of sitting, standing, walking, twisting and bending, repetitive hand motions, light lifting up to 25 lbs, and possible exposure to radiation (e.g., cath labs).
• Ability to work in a controlled environmental area (clean room) with gowning and PPE, and with various chemicals.

Required skills

• Desired: knowledge of cGMP, GDP, QMS and/or ISO regulations, and basic measuring techniques such as calipers and micrometers.
• Desired: knowledge of computer software such as MS Word, Excel, Outlook and Teams.
• Desired: previous experience with video inspection equipment and other inspection tools.