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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. Your responsibilities will include establishing systems that enhance the audit programs at the facility, driving continuous improvements, and minimizing audit findings. You will also maintain the schedule for internal and external audits, prepare for audits, and manage the audit hosting process.
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. Prepare the site for each audit, ensuring that all requested documentation is organized and that the facility is audit-ready. Serve as the audit host, delivering site presentations and conducting facility tours for auditors. Act as the primary contact with auditors before, during, and after the audit process. Manage the receipt of audit reports and coordinate responses, collaborating with management and technical staff to perform root cause analyses and implement corrective and preventive actions to prevent recurrence. Ensure timely submission of responses. Work with observation owners to guarantee that corrective actions for audit observations are completed by the required deadlines. Facilitate near-miss meetings with site 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 KPIs to ensure compliance with internal standards, tracking and trending audit metrics effectively. Utilize knowledge of International Standards and Federal Regulations (e.g., ISO 13485, 21 CFR 820, EU MDR) to uphold the quality management system. Assist with supplier onboarding processes and purchase order generation as needed. 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. Demonstrate consistent, reliable, and punctual attendance. Perform other duties as assigned.Basic Qualifications:
Strong analytical and complex problem-solving skills. 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. Proven experience in completing CAPAs and/or conducting complex investigations.Preferred Knowledge, Skills, and Abilities:
EU MDR auditor certification. CQA/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 contributing to Lean Sigma initiatives aimed at achieving set targets. Willingness to learn manufacturing procedures and assist with improvements through Quality Management. Awareness of all relevant 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 required. 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 essential.