VIVA USA Inc Quality Support in Flanders, New Jersey

Req Ref No: RPNJQS-34 Location: Flanders, NJ Duration: 6 Months



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

VIVA is an equal opportunity employer. All qualified applicants have an equal opportunity for placement, and all employees have an equal opportunity to develop on the job. This means that VIVA will not discriminate against any employee or qualified applicant on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.