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TE Connectivity (NYSE: TEL) is a $16 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: Global Quality Systems Engineer (Change Management/Training)
Job Overview
The Global Quality System Engineer is responsible for supporting, improving, and managing the Global Change Management Process and Global Training Process across the organization. S/he will work closely with the site quality system teams representatives across the organization to ensure harmonized processes are implemented and effective, and serve the business, as well as meeting regulatory requirements. This position will support the Global change management and training requests driven by the Global Quality Systems team as well as support cross-site activities related to the change management and training processes and drive best practice adoption and deployment.
Job Responsibilities
Work with teams to develop & implement QMS documentation policies compliant with regulations & traceability, assist in developing documentation when directed.
Responsible for organizing and overseeing a wide variety of Global quality documents in support of production and development goals.
Works independently to perform multiple tasks in the document control and training areas.
Initiates supports and executes an effective and efficient change control process in accordance with internal and external requirements.
Assists Documentation controllers across the organization with improvement and standardization of Document Change Control processes.
Assists training coordinators across the organization with improvement and standardization of training processes.
Maintains an effective change and version control of all global documents.
Investigates and resolve NCRs, Internal Audits, CAPAs related to Global Documentation Services and training processes.
Provides oversight/support of periodic document review process to drive timely completions.
Assists with reporting and analysis of Change Control metrics
Train new associates or document owners in document management and change management.
Follows all standard operating procedures
Responsible for communicating business related issues or opportunities to next management level
Performs other duties assigned as needed
Experience/Qualification:
Minimal requirements
A Bachelor’s degree and/ or at least 3 years of relevant experience in Quality Systems or Document Management in a regulated industry is required.
Must have a good understanding of quality system requirements and how each quality system element connects.
Knowledge of GDP, CFR 820 and ISO 13485 standard are required.
Experience providing support for internal audits and inspections by regulatory authorities is preferred.
Experience with CAPA, NCR and internal audit process is preferred
Prior exposure to various functions of corporate organization and cross-functional experience is preferred
Experience working with product development and/or manufacturing is preferred
Proficiency in Microsoft Office Applications, Adobe Acrobat, and some knowledge of database application is required.
Experience with Smartsolve eQMS system is an advantage.
Minimal requirements
A Bachelor’s degree and/ or at least 3 years of relevant experience in Quality Systems or Document Management in a regulated industry is required.
Must have a good understanding of quality system requirements and how each quality system element connects.
Knowledge of GDP, CFR 820 and ISO 13485 standard are required.
Experience providing support for internal audits and inspections by regulatory authorities is preferred.
Experience with CAPA, NCR and internal audit process is preferred
Prior exposure to various functions of corporate organization and cross-functional experience is preferred
Experience working with product development and/or manufacturing is preferred
Proficiency in Microsoft Office Applications, Adobe Acrobat, and some knowledge of database application is required.
Experience with Smartsolve eQMS system is an advantage.
Competencies:
Values: Integrity, Accountability, Teamwork, Innovation
Excellent verbal and written communication skills
Ability to work independently and on multiple tasks
Ability to manage tight timelines and changing priorities
Excellent problem-solving techniques
Excellent interpersonal and communication skills are required
Must be detail oriented and accurate and able to quickly adapt and navigate various technology and computer systems.
Ability to communicate with multiple levels of management is required
TRAVEL:
This position does not require travel.
We are an Equal Opportunities Employer
