QuidelOrtho
Healthcare
GlobalComplianceEngineer
“Global Compliance Engineer at QuidelOrtho. Skills: Quality compliance, Global audits. Support audit and inspection readiness activities. Perform internal audits”
Industry & Context.
Up to 15% domestic and/or international travel, Travel to site at short notice when required
What They're Looking For.
Must Have
Bachelor's degree in science, engineering, QA, RA or related business field or equivalent job experience, Previous experience related to compliance processes in a regulated biologics, pharmaceutical and/or medical device environment, Expert knowledge in quality compliance, Previous experience in global internal/external audits, Demonstrable skills in MS Word, Excel, PowerPoint, Adobe, Demonstrable skills in quality system database applications, High degree of confidentiality and professionalism
Nice to Have
Background in IVDD directives, Background in IVDR regulations, Background in ISO 13485/9001, Background in MDSAP standards
What You'll Do.
Support audit and inspection readiness activities
Perform internal audits
Liaise with Quality Operations/Global Supply Network Excellence partners
analyze and share information associated with annual
Coordinate global regulatory inspections
Manage inspection strategy and logistics
Lead inspection readiness meetings
Develop inspection strategy and determine risk
Identify and prepare subject matter experts
Prepare inspection staff
Work closely with site manufacturing lead
Support pre and post activities for external inspections
Liaise with Notified Bodies
Liaise with Regulatory Agencies
Prepare documents for audits
Provide audit oversight
Write audit responses
Track audit follow-up activities
Support other external audits
Conduct internal audits
Support internal audits conducted by consultants
Prepare guidance for internal audit agenda
Identify SMEs for internal audits
Provide oversight during internal audit execution
Review internal audit reports
Manage internal audit follow-up activities
Support metrics tracking for QSE
Maintain QuidelOrtho Global Audit tracker
Create and issue report for overdue and upcoming
How You'll Work.
Team & Collaboration
Quality Operations partners; Global Supply Network Excellence partners; Site manufacturing lead; Key relevant staff
Communication Scope
Response writing
Applying for this Global Compliance Engineer role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about QuidelOrtho?
Real rants from real employees. Read before you apply.