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Internal Audit Program Specialist
Description
About CooperSurgical
CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com.
Work location: Trumbull, CT or Stafford, TX (on-site)
Scope:
The Internal Audit Program Coordinator will support and maintain the global internal audit program for a medical device organization operating under ISO 13485, FDA 21 CFR Part 820/QMSR, MDSAP, and EU MDR requirements. This role focuses on planning, coordinating, and executing internal audits across multiple manufacturing sites and functions, both remote and onsite. Responsibilities include scheduling audits with qualified internal staff and external resources, ensuring compliance with regulatory and quality system standards, and performing audits directly as skills develop. This position is designed for an early-career professional seeking growth in auditing and quality systems, with opportunities to expand technical expertise and assume greater audit responsibilities over time.
Job Summary:
The Internal Audit Program Coordinator supports and maintains the global internal audit program for a medical device organization operating under ISO 13485, FDA 21 CFR Part 820/QMSR, MDSAP, and EU MDR requirements. This role is responsible for coordinating internal audits with qualified internal staff and external resources, as well as performing audits directly as experience grows. The Internal Auditor ensures audits are planned, executed, and documented in compliance with regulatory and quality system standards, contributing to continuous improvement and organizational compliance.
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.
Travel: This position may require 10-20% domestic and/or international travel.
Qualifications
Knowledge, Skills and Abilities:
- 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.
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).
Work Environment:
- Primarily office-based with regular use of computer systems and virtual collaboration tools
- Occasional travel to manufacturing facilities and other company sites for onsite audits
Experience:
- 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.
Preferred
- 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.
- Experience with electronic Quality Management Systems (eQMS).
Education:
- Bachelor’s degree in a relevant field such as Engineering, Life Sciences, or a related discipline.
Preferred
- 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.
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Our Benefits:
As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.
To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.
We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.
