QuidelOrtho
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.
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.
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 of users.
Coordinate training program – Communicate with managers to identify training needs, map out development plans for teams and individuals, configure 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.
Facilitate the Change Control process in the configuration of training requirements.
Assist as required in regulatory inspection activities.
Perform other work‑related duties as assigned.
Qualifications
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.).
Proficiency with Microsoft Office (Word, Excel, Access, PowerPoint, Project), SharePoint, Outlook, Visio, Adobe Acrobat, Articulate, and basic programming skills (HTML, XML, SQL, Visual Basic, Shell scripting).
Effective verbal and written communication skills.
High attention to detail to assure high quality documentation.
Preferred
ASQ Certification.
Working understanding of Quality Management Systems under 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
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, phone calls, and analytical work are common.
Salary Transparency 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.
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 recruiting@quidelortho.com.
Seniority Level
Entry level
Employment Type
Full‑time
Job Function
Quality Assurance
Industries
Medical Equipment Manufacturing
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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.
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 of users.
Coordinate training program – Communicate with managers to identify training needs, map out development plans for teams and individuals, configure 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.
Facilitate the Change Control process in the configuration of training requirements.
Assist as required in regulatory inspection activities.
Perform other work‑related duties as assigned.
Qualifications
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.).
Proficiency with Microsoft Office (Word, Excel, Access, PowerPoint, Project), SharePoint, Outlook, Visio, Adobe Acrobat, Articulate, and basic programming skills (HTML, XML, SQL, Visual Basic, Shell scripting).
Effective verbal and written communication skills.
High attention to detail to assure high quality documentation.
Preferred
ASQ Certification.
Working understanding of Quality Management Systems under 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
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, phone calls, and analytical work are common.
Salary Transparency 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.
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 recruiting@quidelortho.com.
Seniority Level
Entry level
Employment Type
Full‑time
Job Function
Quality Assurance
Industries
Medical Equipment Manufacturing
#J-18808-Ljbffr