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Brisbane, CA – Quality Specialist

Our client, specializing in next-generation automated external defibrillators (AEDs) and cardiac arrest response systems, is currently hiring a Quality Specialist to Perform visual and dimensional inspections of incoming medical device components. Role is a Contract Without an end date.

Summary/Objective:

The Quality Control Inspector is responsible for Quality Control daily activities which include but are not limited to Inspection of Incoming FG and components, including: Performing in-process Lot release LHR/DHR Final inspection and release, Creating and maintaining records for safe long-term storage and organized fast retrieval, and Maintaining inspection and rejection logs. Apply GDP to document quality records and logs.

Essential Duties and Responsibilities:

Perform visual and dimensional inspections of incoming medical device components, in-process assemblies, and finished defibrillator products to ensure regulatory (ISO 13485, FDA) standards and other specifications are met.

Conduct and document incoming, in-process, and final product inspections to ensure conformance.

Approve or reject materials and products; record and communicate findings and defects for non-conformance and root cause analyses.

Use testing and measuring equipment (e.g., calipers, microscopes, gauges) accurately; maintain calibration logs and proper records.

Support investigations into non-conformances, assist with CAPA activities, and participate in internal audit and continuous improvement efforts.

Inspects incoming Finished Goods and components in accordance with written procedures, statistical sampling plans, engineering drawings and specifications as assigned.

Properly identify products and components for traceability.

Release materials to Inventory and production for use according to approved procedures.

Processes RMA’s and product complaints in a timely manner.

Identify, Document, and Contain nonconforming product as appropriate per procedure. Assist in nonconforming product review to efficiently disposition.

Ensured equipment is properly handled and maintained in safe storage when not in use.

Operates inspection and test equipment (e.g., Defibrillator analyzer, caliper, ruler, etc...).

Provides input regarding inspection methods and quality procedures.

Assists with supplier evaluations and performance monitoring through proper data entry in IQC logs.

Aid in preparation and revise controlled documents in accordance with standard formats which may include procedures, forms, and reports pertaining to QC Department

Aid in the release of approved documents and retrieval of superseded /obsolete revisions to prevent inadvertent use from the QC Binder.

Assists in performing process audits to ensure compliance with current practices.

Participate in third party and internal quality audits involving areas of responsibility. Assists with related corrective/preventive action planning and implementation.

Communicate with cross functional groups to bring tasks to closure in a timely manner.

Aid in tracking and reporting on quality metrics and deliverables. Assist in promoting and advancing quality awareness throughout the Company through the expansion and development of the Quality Management System.

Qualifications:

Minimum 2-5 years of recent in-process inspection experience within the medical device, electronics, or aerospace or related industries.

Proficiency in using measuring and testing tools.

Computer proficiency with SAP or related software for performing documentation tasks.

Client’s award-winning AEDs are designed to be intuitive, effective, and widely accessible, aiming to increase survival rates from sudden cardiac arrest by integrating real-time connectivity and innovative support systems within emergency response devices.

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