QA EDMS Specialist

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.

QuidelOrtho is seeking a QA Electronic Data Management System (EDMS) Specialist. The QA EDMS Specialist will be responsible for management functions as they relate to training compliance and the training process automation using the Quality Electronic Data Management System (EDMS) and/or Learning Management System (LMS).

This position will be a hybrid schedule, with onsite in San Diego, CA.

• Administer the EDMS and/or LMS including performing all functions needed to maintain workflows, overseeing the setting of passwords, establishing security rules, and creating user accounts by interfacing with QuidelOrtho or other business site network administrators to establish user identities, system security and resolving EDMS/LMS helpdesk issues.

• Onboarding/Offboarding

• Coordinate training program – Communicate with managers to identify training needs, map out development plans for teams and individuals, configure of training requirements in the EDMS/LMS, and manage training curriculums and plans.

• Provide general EDMS/LMS training and assistance to users on the application(s). Help users resolve “help desk” issues as needed.

• Facilitates the Change Control process in the configuration of training requirements

• Assist as required in regulatory inspection activities

• Perform other work-related duties as assigned

Required

• Associate degree in Business Administration/
  Management, Science or equivalent experience

• 1-3 years of progressively more responsible experience with quality management systems in medical device or other highly regulated industry

• Must have experience with an EDMS, PLM, and/or LMS system (i.e., Master Control, Veeva Vault, OpenText DMS, Windchill PLM, Pilgrim, Agilent PLM, Cornerstone, etc.)

• Any combination of knowledge/skill with: Microsoft Word, Excel, Access, PowerPoint, Microsoft Project, Share Point, Outlook, Visio, Adobe Acrobat, Articulate, Programming: Basic HTML, XML, SQL, Visual Basic and/or Shell scripting (NT/UNIX)

• Effective verbal and writing communication skills

• This position requires high attention to detail to assure high quality documentation

Preferred:

• ASQ Certification

• Working understanding of Quality Management Systems under the following regulations: ISO 13485, FDA 21 CFR 820, European Union MDD and/or IVD

• Advanced skills with Master Control and/or other EDMS/LMS application(s)

Internal Customers:

• Quality Department - Collaborating on department planning and scheduling to meet department and corporate goals and objectives.

• EDMS/LMS “Customers” - Assisting other departments/individuals at QuidelOrtho who need application assistance (i.e. resetting electronic signatures, log in help, etc.).

• Training systems “Customers” – Assisting departments/ individuals at QuidelOrtho who need training systems assistance

The work environment characteristics are representative of both an office, manufacturing, and work from home environment.  Occasional overtime and flexible work hours to meet project deadlines. Occasional travel required. Travel may include airplane, automobile travel and overnight hotel.

Position requires ability to lift up to 30 lbs. on occasion. Walking, standing, and sitting for long periods of time are routine to accomplish tasks in this role. Computer work, paperwork, on phone, doing analytical work

The 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, its 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. The salary range for this position is $49,000 to $66,000 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 the 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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