Responsible for assisting to improve the Quality Compliance of Fort Worth and TJ Smith & Nephew QMS. Primary responsibilities include assisting with Risk Management, Design History Files, Product Release, and revision of documents in the DMS.
Works within the quality management systems and ensuring functional compliance to the applicable FDA’s cGMPs, international standards, Good Distribution Practices and state requirements (Smith & Nephew and outsource suppliers).
Assists in activities within the quality engineering area related to problem solving, in process control charting and annual product report trending of data.
Participates in internal and external audits as needed
Develops plans and works to implement continuous quality improvement programs (e.g., in process control monitoring)
Performs gap assessments for existing QMS and current regulatory requirements
Troubleshoot issues and determine solutions to ensure compliance with applicable regulations
Fort Worth, TX
B.S. Engineering, Biomedical Engineering, Industrial Engineering
None required but relevant certifications are a plus (ASQ-CQE, CQA, etc.)
1 year previous work experience required but previous experience in the pharmaceutical/medical device industry and experience working within a regulated environment is a plus.
Must be able to enter/record data, write/record information. Must have experience with MS Office, Outlook, statistical software
Able to effectively communicate with team leader, other departments, and vendors.
Up to 10%