QA 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 6000 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

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.

The Responsibilities

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

The Individual

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)

Key Stakeholders

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 :

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.

The Physical Demands :

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

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 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 $49000 to $66000 and is bonus 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 Employment 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 r .

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Required Experience :

IC

Key Skills

Invoicing,Information Technology Sales,IT Support,Audio Visual,Database Administration

Employment Type : Full-Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 49000 - 66000