Specialist, Quality Compliance

Ortho Clinical Diagnostics • Rochester, NY

221d • $58,000 - $80,000

About The Position

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

Requirements

• A minimum of an associate's degree in Technical Writing, Communications, Medical Technology, Biology or Engineering with technical writing experience or equivalent is required.
• A minimum of 3 years of relevant work experience is required.
• Must be able to represent the Technical Publications group on cross-functional teams and be comfortable interacting with Engineering, Research & Development, Regulatory, Quality, Customer Support, IT professionals and upper levels of management.
• Must be a proven team player, self-motivated, able to prioritize workload with minimal supervision, manage multiple projects simultaneously and work under tight deadlines.
• Excellent written and verbal communications skills and strong computer skills are required.
• Experience in HTML, XML, DITA, FrameMaker, Microsoft Office and the creation of online documentation using topic-based authoring.

Nice To Haves

• A bachelor's degree is preferred.
• Experience working in a regulated environment.
• Experience with content management systems, CSS and system design.
• Knowledge of animation tools and Java scripting.
• Experience working with translated publications.
• Knowledge of QuidelOrtho products will be a significant advantage.
• Experience in website design/authoring tools.

Responsibilities

• Produces technical publications and communications to support the safe and effective use and servicing of QuidelOrtho Products.
• Projects may include technical manuals, online content, product labeling and instructions for use, communications and presentations delivered in various formats.
• Gathers and organizes technical information from various sources.
• Develops, writes, edits, manages review/approval, and proofreads complex materials for internal and external customers.
• Reviews and analyzes publication/labeling effectiveness and efficiency including verification/validation.
• Follows established change control procedures.
• Ensures publications adhere to established standards of style and format and meet regulatory requirements.
• Reviews published materials and recommended revisions or changes in scope, format, and content.
• Adheres to project timelines and communicates/escalates potential impacts to project schedules.
• Investigates and resolves or escalates customer complaints and concerns and responds to non-standard inquiries.
• Participates in special projects as assigned.
• Perform other work-related duties as assigned.

Benefits

• Comprehensive benefits package including medical, dental, vision, life, and disability insurance.
• 401(k) plan.
• Employee assistance program.
• Employee Stock Purchase Plan.
• Paid time off (including sick time) and paid Holidays.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Associate degree