• Job Description

  Req#: R0211259
  Employer Industry: Healthcare (Medical Devices)
  
  Why consider this job opportunity:
  - Opportunity for career advancement and growth within the organization
  - Significant travel opportunities (30% - 50%)
  - Collaborative work environment focused on quality improvement
  - Chance to work as a Subject Matter Expert in quality systems audits
  - Supportive training initiatives for new auditors
  - Commitment to employee personal and professional goals
  
  What to Expect (Job Responsibilities):
  - Plan, conduct, and lead quality systems audits in accordance with the global audit program
  - Manage internal and corporate audit programs for assigned sites, ensuring compliance with regulations
  - Track and resolve Non-Conformances (NCs) and Corrective and Preventive Actions (CAPAs) identified during audits
  - Prepare sites for external quality management inspections and ensure readiness
  - Develop and maintain audit processes and documentation in line with company policies and regulatory requirements
  
  What is Required (Qualifications):
  - Bachelor’s degree or an equivalent combination of education and experience required (advanced degree preferred)
  - Minimum 10+ years’ experience in quality management, regulatory compliance, quality engineering, and auditing in the pharmaceutical or medical device sector
  - 3rd party auditor training (e.g., ASQ-CQA, ASQ-CBA, RABQSA, ISO 9001:2015) or equivalent required
  - In-depth knowledge of current regulations and standards for pharmaceuticals and medical devices
  - Strong analytical, problem-solving, and communication skills
  
  How to Stand Out (Preferred Qualifications):
  - Experience with FDA inspections and cooperation with US regulatory authorities
  - Demonstrated expertise in specialized processes related to drug and device manufacturing
  - Proficiency in writing and revising Standard Operating Procedures
  - Experience in training and mentoring staff
  - Willingness to travel internationally
  
  #Healthcare #QualityManagement #MedicalDevices #CareerGrowth #Auditing #RegulatoryCompliance
  
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• About the company

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