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Senior Audit Program Specialist
2 months ago
Job Overview
In this position, you will play a crucial role in supporting both external (customer, regulatory, and corporate) and internal audit initiatives for a medical device manufacturing organization. You will assist in developing systems that bolster the audit programs at the facility, aiming to drive ongoing enhancements and reduce audit findings. You will be responsible for maintaining the audit schedule for both internal and external audits, preparing for and facilitating audits, crafting responses to audit reports, and ensuring the completion of corrective actions. Your duties will encompass all compliance-related tasks associated with ISO standards and current Good Manufacturing Practices (cGMPs).
Key Responsibilities:
Oversee the internal and external audit schedule, coordinating customer and regulatory audits as necessary throughout the year. Ensure timely execution of internal audits. Guarantee that the site is adequately prepared for each audit, ensuring that all requested documentation is organized and the facility is audit-ready. Serve as the audit host, delivering site presentations and conducting facility tours for auditors. Act as the primary contact for auditors before, during, and after the audit process. Manage the receipt of audit reports and coordinate the responses, collaborating with management and technical teams to conduct root cause analyses and implement corrective and preventive measures to avoid recurrence. Ensure timely submission of responses. Work with observation owners to ensure that corrective actions for audit observations are completed by the required deadlines. Facilitate near-miss meetings with subject matter experts post-audit to mitigate future findings. Provide training to site personnel on regulatory, ISO, GMP, and GDP standard requirements as necessary. Maintain and update audit databases regularly. Monitor audit key performance indicators (KPIs) to ensure compliance with internal standards and track audit metrics effectively. Utilize knowledge of International Standards and Federal Regulations (such as ISO 13485, 21 CFR 820, and EU MDR) to uphold the quality management system. May assist with the supplier onboarding process and purchase order generation as needed. May conduct internal audits in accordance with ISO 13485, 21 CFR 820, EU MDR standards, and internal procedures. Adhere to all regulations, policies, work procedures, instructions, and safety rules. Exhibit regular, reliable, punctual, and predictable attendance. Perform other duties as assigned.Basic Qualifications:
Strong analytical and complex problem-solving abilities. Bachelor's degree in engineering or a related field, or equivalent work experience. ISO 13485 Lead Auditor certification. Experience in FDA CFRs, ISO 13485, EU MDR, or other regulated environments. Experience in completing Corrective and Preventive Actions (CAPAs) and/or conducting complex investigations.Preferred Knowledge, Skills, and Abilities:
EU MDR auditor certification. Certified Quality Auditor (CQA) or ASQ certification. Ability to interface effectively with customers and meet their expectations. Familiarity with Medical Device regulations. Capability to collaborate with interdisciplinary teams. Experience with project management tools and participation in Lean Sigma initiatives aimed at achieving set objectives. Willingness to learn manufacturing processes and contribute to improvements through Quality Management. Awareness of all relevant Standard Operating Procedures (SOPs) as per company policy related to this position. Compliance with the company's safety policy at all times. Adherence to the company's quality policy at all times.Travel Requirements:
None.Physical and Mental Requirements:
Exceptional attention to detail is essential. Ability to work in both office and manufacturing environments, with the potential need to stand or sit for extended periods. Mental resilience and adaptability are required.