MGR QUALITY/TECH SERVICES

General SummaryThis position is responsible for managing Technical Service Quality Compliance through a variety of technical and administrative duties to support the company’s Medical Device Compliance efforts. This position will function as a liaison between manufacturing, service, and regulatory affairs. These duties have a major impact on the company’s ability to market products in accordance with US and international requirements. Principal Duties and Responsibilities1. Assures that the site Technical Service Systems comply with all applicable sections of 21CFR and its guidelines.2. Provide guidance for Technical Services Management for all Quality regulations and requirements.3. Conduct internal and field Quality audits to assure compliance with domestic regulations and international requirements. 4. Responsible to resolve all department assigned corrective and preventative actions (CAPA’s).5. Seek out and apply best quality assurance methods and practices in support of Quality objectives.6. Assist any function as a technical liaison for specific Quality issues.7. Acts as the primary interface for all department audits.8. Performs special assignments as assigned by the Director, Technical Service.Requirements: Knowledge, Skills and Abilities Required1. Bachelor’s Degree in a technical subject, plus a minimum of three years of applicable experience.2. Experience in dealing with US and international medical device requirements, plus knowledge in ISO 9001 or ISO13485 Quality Standards. 3. Knowledge of CAPA procedures.4. Experience in development of Quality systems for FDA, GMP and Medical Device Directive requirements. 5. Excellent writing and interpersonal skills required.6. Proficient in the use of Microsoft Office (Word, Excel, Access, PowerPoint).7. Accuracy in all documentation and other job functions is required.8. Must be a self-starter with the ability to follow general directions in accomplishing assigned work.9. Ability and skill in training personnel in company policies, procedures, and work instructions.10. Must have the ability to interact with all levels of the organization. To apply online, please use the following link: Apply To Covidien Click here to see all “Covidien� opportunities Visit our web site to learn more about Covidien EMAIL THIS JOB TO A FRIENDCOVIDIEN, COVIDIEN with Logo and "positive results for life" are trademarks of Covidien AG. ©2007 Covidien AG or its affiliate. All rights reserved.