Company Profile:

TE Connectivity Ltd. is a $14 billion global technology and manufacturing leader creating a safer, sustainable, productive, and connected future. For more than 75 years, our connectivity and sensor solutions, proven in the harshest environments, have enabled advancements in transportation, industrial applications, medical technology, energy, data communications, and the home. With 80,000 employees, including more than 8,000 engineers, working alongside customers in approximately 140 countries, TE ensures that EVERY CONNECTION COUNTS. Learn more at www.te.com

Job description:

 

 

TE Connectivity (NYSE: TEL) is a $12 billion global technology leader. Our connectivity and sensor solutions are essential in today’s increasingly connected world. We collaborate with engineers to transform their concepts into creations – redefining what’s possible using intelligent, efficient and high-performing TE products and solutions proven in harsh environments. Our 72,000 people, including over 7,000 engineers, partner with customers in over 150 countries across a wide range of industries. We believe EVERY CONNECTION COUNTS – www.TE.com.

 

Creganna Medical is ranked among the top 10 global companies in the medical device outsourcing industry. The company specializes in the design and manufacture of minimally invasive delivery and access devices for a range of therapies. Serving over 400 companies across 30 countries, Creganna Medical’s customers include the world’s leading medical device and life science companies. Headquartered in Galway, Ireland, Creganna Medical has a global operational footprint with design and manufacturing facilities spanning the U.S., South America, Europe and Asia. http://www.creganna.com/

 

Job Title: eQMS Support Specialist

 

Job Overview

The electronic Quality Management System (eQMS) Support Specialist is responsible for supporting, problem resolution and periodic maintenance of the eQMS software and automated system. This includes establishing periodic support tasks, enhancing the application within the scope of the position, and advising TE Medical Quality on the strategy, policies and best practices for application support. This position will assist in ensuring the eQMS application remains compliant with applicable regulations and standards. This position is part of a global team tasked with supporting a critical global system with approximately 5000 users. He/she will work closely with the global project team and sites to resolve issues, implement system changes and maintain the system. He/she will advise project teams and the business if business processes being automated are not compliant. This position will work closely with the vendor to resolve issue and stay abreast of the patch notices.

              

Job Responsibilities

• Act as customer service for eQMS issues
• Follow up with users on resolutions
• Resolve IT Service Desk tickets
• Serve as the second level contact for all SmartSolve Issues. First level is the corporate service desk.
• Perform remote trouble shooting of SmartSolve issues
• Act as System Administrator for SmartSolve
• Work with the vendor to resolve complex issues
• Working on system process improvement projects
• Maintain resolution logs and knowledge base articles.
• Maintain User accounts, by creating new accounts, inactivating users, assigning rights and roles and annual review of active user accounts.
• Adhere to procedures and work instructions in both supporting the eQMS system and using the system
• Modify system reports using the Business Intelligence tool or local searches
• Maintain an awareness of current TE Computer Systems Assurance processes to support the eQMS
• Advise on eQMS support SOP changes and make changes when tasked. Recommend and/or author new support SOPs when needed.

• Interfaces with other project teams as needed to advise on eQMS capabilities and processes
• Provides support to TE Medical sites during regulatory and customer audits as needed, usually adhoc reporting.
• Monitoring and reporting eQMS performance trends, including escalation to senior management as required.  
• Shift time availability required
• Perform other job-related duties as assigned. 

 

Qualifications

• Bachelor's Degree with a computer or engineering emphasis.
• Minimum 3 years software support experience. This must be more than helpdesk support.
• Fluent in English
• Spanish is an advantage
• Knowledge of eQMS system functions.
• Knowledge of desktop browsers and settings
• Experience supporting software systems using relational databases and an understanding of relation databases
• Experience supporting remotely hosted systems
• Understand the business needs of at least one of the six functional areas used by the eQMS system (Change, Document, CAPA, NC, Internal Audit, and Regulatory Complaints)

 

Desirable Qualifications

• Minimum 2 years in a regulated industry, ideally in a multi-national medical device or pharmaceutical environment. 
• Prior experience with SmartSolve eQMS

 

Key Requirements

To perform this role successfully, the individual should demonstrate the following competencies: strong software support knowledge, Problem-Solving, basic project management skills, Interpersonal Skills, Oral and Written Communication Skills, Judgement, Ability to evaluate information gathered from observation, experience, reasoning, and/or communication, demonstrated clarity, accuracy, precision, independent judgement, and thoroughness. Highly motivated with a sense of urgency. The ability to effectively communicate with users at all levels.

 

Travel

• Travel will be infrequent, but a willingness to travel domestically and internationally as needed dependent on the needs of the organization.

 

Core Values: Integrity, Accountability, Teamwork, Innovation