QuidelOrtho
Healthcare
GlobalComplianceEngineer
Neural analysis suggests this role is
optimal for Mid+ candidates.
“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
Full Job Description
## 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. **Global Compliance Engineer** As part of our continued growth, we are seeking a Global Compliance Engineer to join our team at our state-of-the-art manufacturing facility in Pencoed. This is a permanent role offering hybrid working. However, given the nature of the position, the successful candidate will need to be able to travel to site at short notice when required. **Your new role:** As the Global Compliance Engineer, you will be a key member of the Global Compliance team. In your role, you will support audit and inspection readiness activities of the global quality system and processes to assure each area is able to successfully demonstrate compliance during internal and external inspections. This role reports into the Quality Systems Excellence Manager, Planning and Monitoring. You will perform Internal audits in accordance with QMS standards and regulatory requirements impacting QuidelOrtho’s global quality system. Liaising with Quality Operations/Global Supply Network Excellence partners to collect, analyze and share information associated with annual audit activities across QuidelOrtho, to assure visibility and consistency across the QRC organisation. **What yo
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