**Vacancy Name** Junior Configuration Management Engineer. **Location of Work** Tijuana, Mexico **Employment Type** Full Time Employee **Job Description** **Our brand promise** **We deliver a collaborative experience by working directly with the surgical community to ensure you get the exact surgical tools you need at the right time and the right price.** * **Remarkable service** **A seamless, personal process designed around you and your needs.** * **Trusted performance** **Our product family is the result of years of experience championing surgeons and listening to their expertise.** * **Outstanding value** **No matter the surgical specialty, we deliver quality products for all markets.** **Our people promise** **Excellence is our specialty and what makes us successful is our people. We are committed to fostering a positive, empowering and growth\-oriented environment where all team members are encouraged to share their opinions and ideas. That means you will work alongside an accomplished and highly collaborative team that inspires commitment to our goal in attaining excellence in everything they do.** **Job Purpose Summary** **The role of Jr Configuration Management Engineer is to ensure that the change control process is being done according to procedure, regulations and timeline and to facilitate change control activities from any requiring department to the Configuration Management team. It is in charge of constantly improving processes related to configuration management and document control. This role assists in internal \& external audits, review and provide guidance to engineers in generating change controls (CC) and Document Change Controls (DCC) \& for all documents to comply with Document Control procedures, applicable standards and regulations. The role also provides support to Customer Service, Marketing, Regulatory Affairs \& Distribution Center on system issues and maintenance. Job functions include, but are not limited to the following:** * **Ensure that Document Control, Change Control and DHR Control processes are properly followed.** * **Updates SOPs for Configuration Management processes and maintains current practices well documented.** * **Ensures that documentation is issued and reviewed in accordance with good manufacturing practices, ISO 13485, CFR 21 Part 820 requirements and other applicable standards and regulations.** * **Maintains the revision of documents and ensures all procedures are updated as needed within the Quality Management System.** * **Support to internal \& external audits.** * **Provide assistance to users in Veeva \& D365\.** * **Assist on the development of procedures, processes and change requirements for applicable areas in Configuration Management.** * **Ensure temporary deviations meet the requirements to be issued.** * **Periodic QMS documentation review.** * **Provide training on QSR, GMP and GDP.** * **External Document and Standards control and management.** * **Optimize and analyze data regarding CCs, DCC and Deviations.** **What you will need** **Establish direction, plan, and organize workloads by estimating, scheduling, distributing, and controlling work assignments to provide for a smooth flow of both priority and routine tasks to achieve economical and efficient utilization of personnel and facilities.** **Ensure key business metrics are achieved within the area and drive corrective action of related non\-conformances.** **Identify and resolve performance problems within the document control process.** **Promote a strong sense of teamwork among personnel throughout and across the area.** **Provides leadership consistent with the Mission and Guiding Principles.** **Serve as the focal point to communicate and resolve issues within their area and other internal customers.** **Coordinate with internal customers as necessary to ensure commitments are achieved. Facilitate problem solving and collaboration.** **Identify errors and initiate corrective action while monitoring the quality date to ensure the effectiveness of the corrective action.** **Support corrective action reviews and participate in identifying root causes and corrective actions within the processes of the area.** * **Professional career** * **2 to 5 years of experience** * **English at a B2 Level as minimum** * **Attention to detail and highly organized** * **Good understanding of QMS principles, document control, nonconformance/CAPA systems.** * **Working knowledge of ISO 13485, FDA 21 CFR 820, and related standards and regulations**