Jobs in Brea, CA

About the role

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:

What you'll bring

• 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)
• Technical writing or copy-editing background
• Experience working with translations and localization of written content