GLOBAL QUALITY SYSTEMS ANALYST

Global Quality Systems Analyst

IRI believes in commitment, integrity, and strategic workforce solutions. Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled, and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow. We've stayed true to our focus of finding qualified and experienced professionals in our specialty areas. Our partner-employers know that they can rely on us to find the right match between their needs and the abilities of our top-tier candidates. By continually exceeding their expectations, we have built successful ongoing partnerships that help us stay true to our commitments of performance and integrity. Our team works hard to deliver a tailored approach for each and every client, critical in matching the right employers with the right candidates. We forge partnerships that are meant for the long term and align skills and cultures. At IRI, we know that our success is directly tied to our clients' success.

Job Description

The Global Quality Systems Change Analyst assists in the review, release, and implementation of global quality documents via the change order process. The GQS Change Analyst ensures documentation and record keeping processes conform to all applicable internal procedures and external medical device regulatory requirements. The individual will assist in the day-to-day document control activities within the Global Quality Systems documentation team. Essential functions include at a minimum:

• Performs document control functions by initiating change orders to effectively route, track, process, review, distribute, release, and archive documents
• Collaborates with cross-functional teams and Global Process Owners in the timely release of documents via the change order process
• Organizes and ensures accurate and reliable document requests using SharePoint
• Provides a thorough review of document content prior to routing to ensure adherence to internal processes
• Works closely with translation agency to coordinate document translations
• Adheres to internal processes and provides input for process improvement
• Proactively initiates, develops, and maintains effective working relationships with team members

Qualifications

Bachelor's degree in scientific discipline or an equivalent combination of skills, education, and experience

Quality professional with 3-5 years of experience with document management in a regulated industry pharmaceutical or medical device industry with direct document control and change order system experience

Excellent analytical, verbal communication, and writing skills

Self-starter able to manage multiple competing demands

Proficient at reviewing and editing documentation

High-level critical thinking and problem-solving skills

Skilled in the use of a Product Lifecycle Management (PLM) system, MS office applications such as Word, Excel, PowerPoint, and Adobe Acrobat

Self-motivated with ability to implement, organize, and prioritize multiple tasks to meet deadlines

Ability to effectively build and maintain relationships with all levels of management

Knowledge of industry regulations to include 21 CFR 11, ISO 13485, ISO 9001, Good Documentation Practice (GDP)

Preferred Skills

Technical writing or copy-editing background

Experience working with translations and localization of written content