Quality Systems EDMS Specialist

The Opportunity

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.

The Role

As we continue to grow as QuidelOrtho, we are seeking a Quality Systems EDMS specialist responsible for supporting the EDMS (Electronic Database Management System) and to provide Quality Management System (QMS) solutions to support growth and continuous improvement. The Quality Systems EDMS specialist works independently or under the direction of an EDMS Administrator. The role serves as a sub-administrator the EDMS under Master Control (MC) and/or similar applications. This individual actively supports corporate strategic goals and objectives through oversight of the EDMS.

This position is located in San Diego, CA. This is a hybrid position with 2 days a week in office.

The Responsibilities

• Manage the EDMS including performing all functions needed to oversee the setting of passwords and creating user accounts by interfacing with Quidel or other business site network administrators to establish user identities, system security and resolving MC 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, and manage training curriculums and plans.

• Provide general EDMS training and assistance to users on the MC application. 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 duties & projects as assigned

The Individual

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

• 2-4 years of experience with quality management systems in medical device or other highly regulated industry required

• Must have experience with an EDMS system (i.e., Master Control, OpenText DMS, Veeva, Agile, Trackwise, etc.)

• Knowledge of federal and other regulations (e.g., QSR’s, ISO 13485, MDSAP)

• Must have advance skills with Master Control and/or other EDMS application(s).

• Must have any combination of knowledge/skill with: Microsoft Word, Excel, Access, PowerPoint, Microsoft Project, Share Point, Outlook, Visio, Adobe Acrobat; ISI Toolbox, Compose Plug-In, Macromedia Dreamweaver, Crystal Reports XI, Business Objects Xi, DocComposer, Adlib Express, Oracle Calendar, Learning Management Software (LMS) (i.e., Cornerstone, Saba, TalentLMS, etc.)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.

• Travel less than 10% to local sites.

Key Working Relationships

Internal Partners:

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

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

• Training systems “Customers” – Assisting other departments/individuals who need assistance.

External Partners:

• n/a

The Work Environment:

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

Physical Demands:

Position requires ability to lift up to 30 lbs. on occasion. Typically, 45% of time in meetings; 55% of time at the desk on computer/doing paperwork/ on phone, doing developmental work. Walking, standing, and sitting for long periods of time are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Position may be required to use Personal Protective Equipment as posted.

Salary Transparency

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, 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 the facts and circumstances of each case. The salary range for this position is $27.00 to $32.00 hourly. 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.

Equal Opportunity

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].