Quality Assurance Technician

Capstan Medical Inc.; Santa Cruz (CA); Hybride; USD 60 000 - 90 000; Plein temps

Résumé du poste

Capstan Medical Inc. is seeking a Quality Assurance Technician to support production-line inspections of implantable heart valve devices. The role emphasizes adherence to QA procedures and precise data recording.

Responsibilities include executing inspection and test procedures, reviewing Device History Records, and assisting in environmental monitoring and non-conformance remediation to ensure compliant product disposition.

Qualifications

• AA degree or equivalent directly transferrable work experience.
• Minimum of 3 years of professional experience in a Class III medical device manufacturing environment.
• Knowledge of quality inspections and record keeping.

Responsabilités

• Support production-line QA inspections for implantable devices (heart valve).
• Assist in inspection/test procedures to evaluate new products.
• Review Device History Records for sub-assemblies and finished goods.
• Assist in quality inspections of purchased components and related record keeping.
• Support remedial actions with QA to disposition non-conforming product.
• Assist environmental monitoring processes and related records.
• Operate equipment used in testing and cleaning activities.

Connaissances

Read prints

Visual inspection

Data entry

Formation

AA degree or equivalent

Description du poste

Description:

• Provide support in production-line Quality inspections for implantable medical device (heart valve)
• 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.

Skills:

• Ability to read manufacturing prints and identify associated specifications/characteristics related to inspection and testing to be performed
• Ability to perform visual inspections (i.e. detect defects) using a microscope and/or magnification visual inspection system
• Ability to use computer and general office software for data entry

Requirements:

• AA degree or equivalent directly transferrable work experience
• Minimum of 3 years of professional experience working in a Class III medical device manufacturing environment