Global Corporate Auditor gn
Global Corporate Auditor gn
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Primary Function of Position
The Global Corporate Auditor will support the of an efficient and effective Quality audit program. They will support the internal external supplier and clinical audit programs to ensure compliance to the applicable regulatory requirements and standards. This individual will have a clear understanding of applicable laws and regulations in order to identify and manage the companys risks appropriately. They will use Quality Auditing principles tools and techniques to support quality systems and processes aligned with the overall Company strategy and mission affecting continuous process improvement. They will ensure effective closure of audit findings by working with cross functional and varying level of departments/business partners to ensure comprehension development and of corrective/preventive action and evaluation of effectiveness checks. They will assist with gap assessments including working with functional area owners to close regulatory gaps. They will continually educate the organization on effective compliance systems processes in alignment with applicable laws and regulations. They will support the quality and regulatory improvement projects and provide insight for longterm strategic QMS improvement.
Roles and Responsibilities:
- Conduct internal audits across all global sites.
- May also coordinate internal audits and provide oversight to external contractors.
- Support supplier and clinical audits as assigned.
- Support external audits or regulatory inspections across global sites
- Complete gap assessment for regulations regulatory standards and corporate procedures
- Train company employees on Quality System Regulations and quality system foundational principles
- Work together with strategic partners across global sites to assure compliance with all company procedures and regulatory requirements.
- Support Quality System projects for new and changing regulatory requirements Serves as the lead coach/consultant to educate internal customers on regulatory compliance processes and regulations
- Create approve and maintain company quality documents such as quality procedures work instructions and forms
- Support CAPA program as audit findings are an input to the CAPA process.
- Review approve provide feedback on CAPA documentation as assigned
- Analyzes quality data and provides compliant pragmatic guidance to support Regulatory Compliance activities including responses to agency requests for information and analyses to support quality improvement projects.
- Prepare responses to regulatory audit observations.
- Ensure that responses are clear comprehensive accurate and well written to mitigate potential for further regulatory actions.
- Provide data to support; Risk based audit schedule process analysis process controls FDA trending and finding history and needed process improvements activities
- Support implementation and continuous improvement of the audit programs auditor qualification programs and companywide inspection readiness.
- Support consult train and lead quality improvement projects
- Provide Quality System Consultation Support new site integration activities across global sites
- Assist in the development and reporting of Quality System Metrics and KPIs
Qualifications :
Required Knowledge Skills and Experience:
- ISO certified lead auditor (ISO 9001 ISO 13485 and/or ISO 14155 or ASQ CQA)
- Minimum 2 years of FDA /ISO 13485 lead auditing experience
- Minimum 5 years of experience in quality in the medical device industry
- Previous experience conducting internal audit is must
- Experience conducting supplier and clinical site audit is a plus
- Quality Engineer Software Quality and Validation experience is a plus
- Strong knowledge of EUMDR ISO 13485:2016; Medical Device Single Audit (MDSAP) and 21 CFR 820 requirements Health Canada and other international regulatory requirements
- Previous experience participating in notified body and FDA inspections
- Familiarity with GMPs related to Combination and Drug Products
- Ability to work on virtual teams remote management; selfdirected
- Ability to be a team player and a partner to the cross functions teams; be part of the solution and demonstrate ability to use riskbased judgment.
- Critical thinking skills and a passion to work in a fastpaced industry with complex/cutting edge technology
- Strong organizational written and verbal communication skills remote working apps and the proven ability to prioritize tasks effectively in a deadlinedriven environment
Required Education and Training
- Minimum Bachelor of Science degree in Technical Engineering or Science related field.
Additional Information :
Intuitive ist ein Arbeitgeber der gleiche und gerechte Beschftigungsmglichkeiten bietet. Wir bieten allen qualifizierten Bewerberinnen und Bewerber gleiche Beschftigungsmglichkeiten unabhngig von ethnischer Herkunft Geschlecht Schwangerschaft sexueller Orientierung Geschlechtsidentitt nationaler Herkunft Hautfarbe Alter Religion geschtztem Veteranenstatus Behindertenstatus genetischen Informationen oder einem anderen Status der nach den geltenden Gesetzen auf Bundes Landes oder lokaler Ebene geschtzt ist und verbieten jegliche Form von Diskriminierung und Belstigung.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
