Manage all activities as they relate to QA activities. Responsible in assisting Quality Engineering and Management in directing projects to ensure product quality and conformance to engineering and customer/federal specifications in the most effective and economical manner possible. This responsibility includes but not limited to the quality control and assurance of components, product and system as well as maintaining Quality System processes.
Our cardiac care product range includes technologically advanced left heart products for critically ill cardiac patients and right heart catheter products, including thermodilution and Berman cathethers, pacing catheters and transradial access products. Teleflex’s Arrow line of intra-aortic balloon catheters and balloon pump consoles is the result of years of clinical and engineering expertise from multiple venues that have come together to bring to market innovative cardiac assist products for critically ill patients who require balloon pump support. In addition to options for balloon pump consoles, we also offer a wide array of intra-aortic balloon catheters with styles from firm to flexible and wire-reinforced catheter bodies to polyurethane.
Take responsibility for the QA team for product and process support.
2. Drive process improvements, quality system improvements, as well as cultural change.
3. Assist in preparations of policies and procedures to comply with regulatory requirements.
4. Develop and analyze quality trend data and manage development of specifications, and establish optimal quality levels.
5. Ensure conformance of ISO 13485:2003, ISO 14971, the Medical Device Directive (93/42/EEC), U.S. Food and Drug Administration’s Good Manufacturing Practice for Medical Devices (21 CFR 820), and CMDR.
6. Responsible for detecting, identifying, correcting and preventing reoccurrence of problems within the quality system.
7. Work with engineering and manufacturing personnel and in conjunction with them resolve problems of product design, specifications, materials, tooling, and production operations affecting quality.
8. Participate in customer and supplier visits as required to confer on specific quality problems.
9. Control inspection, rework, and reprocessing of customer returns (where applicable).
10. Participate in audit of the plant for conformance with FDA Good Manufacturing Practices and ISO 13485 requirements.
11. Assist in the direction of Documentation, Incoming, Calibration, Inspection, Release and Quality Systems Departments to ensure the maintenance and development of new and existing products to the Everett facility.
12. Help to develop and maintain an effective organization through selection, training, compensation, and motivation of all assigned personnel.
13. Maintain Dock to Stock Program.
14. To Aid in the development of product test procedures and evaluation for release.
15. To provide support and initiative in the documentation, development, and release of new product, and new versions of products.
1. High School degree or GED required. Must demonstrate the ability to read and write English, and to do simple to complex mMust possess
3-5 years of experience in quality management with previous experience in a medical device firm.
Knowledge of Certified Standards. Excellent written and verbal skills and the ability to supervise employees
and work with all levels of management.
Teleflex is a global provider of specialty medical devices used for a range of procedures in critical care and surgery. We serve hospitals and clinicians in more than 130 countries with well known, trusted brands in vascular access, general and regional anesthesia, urology, respiratory care, cardiac care, and surgery. We also provide products and services for device manufacturers. Our products are designed to cost effectively provide clinical benefits and enable healthcare providers to improve outcomes and enhance patient and provider safety.
Teleflex Medical - 30+ days ago