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Quality Engineer 1
Ref No.: 18-15422
Location: Flanders, New Jersey
THIS REQ IS REPLACING 48808 AND 49770. PLEASE DO NOT RESUBMIT ANY CANDIDATES THAT WERE ALREADY ON THOSE REQS.

Description:

Must have GD&T CMM Inspection for Medical Device or related industry

Incoming Inspection/Final Release Technician
The Product Final Release/Incoming Inspection Technician will support the release of material to the line and finished product. The position interacts with all levels of employees and management. The nature of these interactions includes answering release criteria questions, problem solving and quality and compliance issues. This position requires independent thinking, interpersonal and communication skills. The problems are usually technical, quality or compliance related in nature.

Job Responsibilities

Reviews all medical device test data and Device History Records to ensure all required specifications are met prior to product release and incoming inspection as needed.
Acts as a liaison between Production and Engineering in the resolution of release criteria

Ensures documentation requirements are met according to Operating Procedures, QSR and ISO standards.
Ensures failure analysis, re-test and corrective actions are documented.
From time to time, the incumbent’s supervisor/manager may assign additional unlisted duties/responsibilities on a temporary or regular basis depending on business needs.
Incumbent is responsible for understanding the Quality Management System.
Assist quality team members with capability and R&R studies as needed
Inspects, tests, or measures materials, products, installations, or work for conformance to specifications
Supports Manufacturing departments in maintaining compliance with applicable standards and regulations

Education and Experience

Associate’s Degree in technology or equivalent program, or completion of a Technical School with at least two years of relevant experience or the equivalent in related work experience

Experience on Final Inspection related activities in a medical device manufacturing environment preferred
Experience on Incoming Inspection. GD&T a must

Special Requirements/Certifications
Knowledge of requirements and regulations related to ISO 13485
Knowledge of requirements and regulations of FDA CFR for Medical Devices

Knowledge, Skills and Abilities
Must have the ability to lift up to 25 lbs as needed
Advanced knowledge in GD&T
Proficient skills in SAP
Demonstrated attention to detail and accuracy
Must be able to effectively communicate with Engineering, Production personnel, Supplier Operations and Materials in order to communicate and resolve inspection issues