Quality Control Technician 2
Business Unit: Laboratory Diagnostics
Requisition Number: 233648
Primary Location: United States-New Jersey-Flanders
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Associate's Degree / College Diploma
Travel Required: 10%
At Siemens Healthineers, we are passionate about enabling healthcare professionals to deliver high quality patient care, and to do so affordably. A leading global healthcare company, Siemens Healthineers continues to strengthen our portfolio of medical imaging and laboratory diagnostics, while adding new offerings such as managed services, consulting, and healthcare IT services – as well as further technologies in the growing market for therapeutic and molecular diagnostics.
Siemens Healthineers develops innovations that support better patient outcomes with greater efficiencies, giving providers the confidence they need to meet the clinical, operational and financial challenges of a changing healthcare landscape.
The Product Final Release Technician will support the release of 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.
ESSENTIAL JOB FUNCTIONS:
1. Manages and maintains quality documents related to the final release of instruments.
2. Reviews all medical device test data and Device History Records to ensure all required specifications are met prior to product release.
3. Acts as a liaison between Production and Engineering in the resolution of release criteria.
4. Ensures documentation requirements are met according to Operating Procedures, QSR and ISO standards.
5. Ensures failure analysis, re-test and corrective actions are documented.
6. 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.
7. Incumbent is responsible for understanding the Quality Management System.
Associate’s Degree in technology or equivalent program, or completion of a Technical School with at lease two to five years of relevant experience or the equivalent in related work experience.
Experience on Final Inspection related activities in a medical device manufacturing environment preferred.
Must be able to effectively communicate with Engineering, Production personnel, Supplier Operations and Materials in order to communicate and resolve final inspection issues.