IQC Quality Assurance Technician

Capstan Medical, Inc.•Santa Cruz, CA

3d•Onsite

About The Position

The IQC Quality Assurance Technician is responsible for inspecting incoming medical device components and materials to ensure they meet quality standards and regulatory requirements. This role supports incoming quality control activities, performs visual and dimensional inspections, reviews quality documentation, assists with nonconformance investigations, and helps maintain accurate quality records in a Class III medical device manufacturing environment. The technician works closely with Quality and Manufacturing teams to ensure the safety, reliability, and compliance of implantable medical devices and related equipment.

Requirements

High School graduate; AA degree is a plus
2-3 years of experience working in a Class III medical device manufacturing environment is preferred
DHR (Device History Record) review experience is a plus
Experience with structural implant heart devices is preferred
Ability to perform visual inspections (i.e. detect defects) using a microscope and/or magnification visual inspection systems, calipers, etc.
Ability to read manufacturing prints and identify associated specifications/characteristics related to inspection and testing to be performed
Ability to use computer and general office software for data entry

Responsibilities

Provide support in incoming Quality inspections for implantable medical device and/or capital equipment
Provide support in execution of inspection and/or test procedures to evaluate all aspects of development of new products.
Provide support in review of Quality records such as Device History Records of product sub-assemblies and/or finished goods.
Provide support in Quality inspections of supplied medical device components and associated record keeping.
Assist Quality Assurance team in remedial actions to support disposition of product or component non-conformance
Assist in environmental monitoring processes and associated record keeping.
Operate specialized equipment that supports established test and/or cleaning activities.