CooperCompanies · 8 hours ago
Internal Audit Program Coordinator
95 Corporate Drive, Trumbull, CT, 06611, US
Full-time
Hybrid
Entry Level
1+ years expCooperSurgical is a leading fertility and women’s healthcare company dedicated to supporting patients throughout their lifetimes. The Internal Audit Program Coordinator will support and maintain the global internal audit program, focusing on planning, coordinating, and executing internal audits across multiple manufacturing sites and functions.
Medical Device
Responsibilities
Plan and coordinate the global internal audit schedule to ensure compliance with ISO 13485, FDA 21 CFR Part 820/QMSR, MDSAP, and EU MDR requirements
Organize and facilitate internal audits by scheduling qualified internal auditors and external resources; accountable for ensuring audits are completed per established timelines and scope
Conduct internal audits (remote and onsite) of manufacturing facilities and supporting functions; accountable for identifying nonconformities and opportunities for improvement
Prepare and maintain audit documentation including audit plans, checklists, reports, and corrective action follow-up; accountable for accuracy and completeness of records in accordance with company procedures
Monitor and track audit findings and corrective actions to closure; accountable for resolution and status reporting to management
Support continuous improvement of the internal audit program by recommending process enhancements and best practices; accountable for contributing to program effectiveness and compliance
Collaborate with cross-functional teams to ensure audit readiness and regulatory compliance; accountable for effective communication and coordination across departments
Serve as the process owner for the internal audit program and defend the process during external audits or regulatory inspections; accountable for demonstrating compliance and effectiveness of the internal audit process
Perform other related duties as assigned, including assisting with quality system projects and compliance initiatives; accountable for supporting overall quality objectives
Qualification
Required
Knowledge of ISO 13485, FDA 21 CFR Part 820/QMSR, MDSAP, and EU MDR regulatory requirements
Understanding of internal audit principles and practices within a regulated environment
Strong organizational and coordination skills to manage audit schedules and resources
Ability to read and interpret technical and regulatory documentation
Proficient in Microsoft Office applications (Word, Excel, PowerPoint)
Effective written and verbal communication skills (English)
Ability to work independently and collaboratively across global cross-functional teams in a regulated environment
Ability to work in a fast-paced setting with shifting priorities while maintaining attention to detail and compliance standards
1–3 years of experience in quality systems or internal auditing within a regulated med tech industry
Hands-on experience coordinating and/or supporting internal audits
Familiarity with ISO 13485 and FDA 21 CFR Part 820/QMSR requirements
Bachelor's degree in a relevant field such as Engineering, Life Sciences, or a related discipline
Preferred
Experience conducting internal audits in a medical device or similarly regulated industry
Familiarity with risk-based auditing techniques
Knowledge of additional quality management standards (e.g., ISO 9001)
Advanced proficiency in Excel for data analysis and reporting
Professional certification such as Certified Quality Auditor (CQA) or similar
Experience with electronic Quality Management Systems (eQMS)
Experience conducting internal audits in a medical device or pharmaceutical environment
Exposure to EU MDR compliance requirements
Prior involvement in managing audit schedules and working with external auditors
Professional certification such as Certified Quality Auditor (CQA), ISO 13485 Lead Auditor, or equivalent
Membership in professional organizations such as ASQ (American Society for Quality) or similar
Benefits
Medical coverage
401(k)
Parental leave
Fertility benefits
Paid time off for vacation
Personal, sick and holidays
Multiple other perks and benefits
Company
CooperCompanies
CooperCompanies (Nasdaq: COO) is a leading global medical device company focused on helping people experience life’s beautiful moments through its two business units, CooperVision and CooperSurgical.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Agostino Ricupati
SVP Finance - Tax and Chief Accounting Officer
June White
Principal Business Partner, Inclusion & Diversity
Recent News
2024-05-04
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