Sr. Quality Engineer

SUMMARY OF POSITION:Covidien's Greenville, IL Plant has an opening for a Sr. Quality Engineer. This position is to ensure that plant operations meet all regulatory compliance requirements. Maintains current knowledge and state regulations regarding validation and cGMP’s and proactively champions validation initiatives to meet same. Work with cross functional departments to maintain adequate records such as management of change records, validation records and reports, etc., as required to establish control of all processes, systems and equipment. Also, this position will design, develop, and execute validation protocols. Review and approve Engineering Change Control, Plant Validation Protocols and Reports. Develop, implement, and maintain technical quality assurance systems and activities. Coordinate revalidation/certification program. Establish, coordinate, and champion site Master Validation Plan. Write and revise SOPs as necessary.Essential Functions:1. Coordinate projects through validations, transfers and/or exhibit studies. Facilitate, coordinate, and champion investigations.2. Coordinate activities in support of the Quality Department priorities with the assistance of the department manager.3. Work with Manufacturing to investigate and resolve process and product quality issues (customer complaints and CAPAs).4. Evaluate, prepare, and maintain validation records in accordance with the validation procedures. 5. Ability to write technical documents with high degree of accuracy.6. Utilize and interpret appropriate quality measures using statistical tools (i.e. SPC, FMEA, DOE, Control Plan, etc.)7. Develop and conduct protocols for validating or revalidating current equipment and processes to assure capability and compliance in meeting quality expectations.8. Support Change Control process, review and approve batch documentation and process changes.9. Identify opportunities for continuous improvement. Utilize Lean and Six Sigma Methods where appropriate. 10. Write/revise Standard Operating Procedures and other GMP controlled documents to ensure a high level of quality and compliance.11. Track, trend and disseminate key quality metrics to the appropriate individuals to incorporate proactive as well as reactive responses in approaching quality issues.12. Participate and conduct the Annual Product Review report process.13. Propose, develop and lead projects to improve the quality systems.14. Support and participate in Site’s Safety, Environmental and Quality Programs.Requirements: B.S. Degree in Engineering or science related field. A minimum of 5 plus years experience in the pharmaceutical industry (primary in Quality environment). Familiar with FDA regulations and Good Manufacturing Procedures. Familiar with ICH Guidelines (Q7) for API's Experience with Quality and validation methods and documentation. Strong written and verbal communication skills. 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.