Specialist, Quality Compliance

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.

As we continue to grow as one, QuidelOrtho, we are seeking a Technical Communications Specialist II to work in our Technical Publications group. The Technical Publications department of QuidelOrtho creates and maintains technical publications about QuidelOrtho products for use by customers and field service personnel. This includes user manuals, service manuals, reagent instructions for use, technical communications, and other forms of labeling and user aids. All publications must be error-free and compliant with FDA and other regulatory authorities worldwide.
This position will be onsite working in a hybrid schedule (2-3 days) at our Rochester, NY facility.

• 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.

Required:

• 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.

• The individuals 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 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.

Preferred:

• 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

Internal:

Technical Subject Matter Experts in Research & Development, Technical Support, Regulatory Affairs, Quality and Compliance, Product Management/Marketing, Post Market Risk Management (PMRM), Information Technology (IT)  

External:

Illustrators, Translation Vendors, Print/Media Vendors, External Manufacturers (OEMs)

Traditional office workspace or remotely.

Position requires Sitting, Repetitive movements of hand(s), Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm, Computer work.

Salary range for this position takes into account a wide range of factors including: education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on that facts and circumstances of each case. Salary range for this position is $58,000 to $80,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time) and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.

QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at [email protected].

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