Maintenance and Calibration Coordinator - 1st shift - FLAG - Gore is a technology-driven global company built on entrepreneurial innovation, integrity, and teamwork. Our diverse portfolio includes everything from high-performance fabrics and implantable medical devices to industrial manufacturing components and aerospace electronics. Through our product leadership, we've been changing lives and changing industries for more than 50 years. What can you change by joining Gore? Visit gore.com/change-life to find out. Job Description Gore Medical Products has provided creative therapeutic solutions to complex medical problems for 40 years, saving and improving the quality of lives worldwide. As a leading manufacturer of vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair, and sutures, we are looking for a Maintenance and Calibration Coordinator to join our team in Flagstaff, Arizona. If you are searching for a company where you can make a difference, were looking for you. In this role, you will Ensure Quality System compliance as it relates to Maintenance and Calibration records The ideal candidate will: * Be passionate about providing support for state-of-the-art implantable medical devices * Be energized by working for a world-class manufacturer and collaborating on cross-functional teams * Recognize the importance of building and maintaining strong interpersonal relationships Responsibilities include: * Performing Quality System compliance as it relates to Maintenance and Calibration (M&C) documentation in accordance with applicable regulations; 21CFR58, 21CFR820, ISO 13485, etc * Ensuring scheduled work is complete, on time and documented properly * Ensuring new assets are documented properly (including relocations and status changes) * Ensuring unscheduled work is documented properly (including issues that require NOAs) * Ensuring equipment is pulled on time and sent out to outside vendors when necessary and, upon return of equipment, reviewing calibration certificate and properly document * Scheduling and escorting on-site visits by outside vendors and document activities appropriately (if required) * Being a divisional resource for M&C Quality System compliance as it relates to engineering, shop, and Quality Assurance (QA) * Additional responsibilities: * Running metrics for shop, engineering, MFG and QA (include QCDSP and TRB if applicable) * Performing Change Orders (COs) to improve M&C documents (If Applicable) * Improving our Quality System as it relates to M&C * Helping the shop become more efficient by streamlining activities and evaluating intervals * Using a continuous improvement mind set to make all aspects of the calibration process more effective and efficient * Performing regular interaction with M&C software, including but not limited to quality record review, data entry, and data mining * Maintaining regular communication with large customer base; i.e. Engineering, Leadership, Purchasing, and Vendors (when applicable) * Being the local plant audit representative in support of the Divisional Audit SME * Acting as first point of contact for M&C software training and questions * Facilitating onboarding training for new Associates that will be interacting with the M&C shop * Maintaining legacy M&C records Required Job Qualifications: * Two year degree or equivalent applicable asset management/database experience * Working experience within a Quality System including, Change Orders, Corrective and Preventative Action (CAPAs) and Notice of Action (NOAs) * Knowledge of M&C regulations, standards, and guidance documents (21 CFR Part 820, ISO 13485, NIST, Comprehensive Dictionary of Measurement and Control; Good Practice Guide to * Calibration Management; etc.) * Strong interpersonal skills * Conflict resolution skills * Basic computer skills (e.g. MS Word, Excel, PowerPoint, Visio, Lotus Notes) * Detail Oriented * Excellent communication skills both written and verbal * Ability to: * Work effectively in a team environment as well as independently * Drive change and consistency across teams * Influence and motivate others * Prioritize and multitask, as well as setting and meeting aggressive timelines * Partner broadly with flexibility, providing a high level of motivation and mentorship skills Desired Job Qualifications: * Bachelors degree * Experience with: * Calibration management systems * Auditing * Supporting Notified Body inspections/audits * Leadership * Document control and change management * Scheduling and coordinating maintenance operations * Blue Mountain RAM software or equivalent * Performance of M&C work Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening. Gore requires all applicants to be eligible to work within the US. Gore generally will not sponsor visas unless otherwise noted on the position description. Gore is a M/F, Disabled and Vet EEO/AA Employer. (Applies to all positions in the U.S.)Keywords: Gore, job, Flagstaff, AZ, Phoenix, Arizona, machine, calibration, coordinator, quality, regulation, document, shop, guidance, change, order, CAPA, NOA, **Primary Location: **North America-United States-Arizona-Flagstaff **Work Locations: ** **Job: **Manufacturing/Operations **Organization: **W. L. Gore & Associates Inc. **Shift: **Day (1st shift) **Travel: **Yes, 5 % of the Time