Employer Industry: Medical Technology

Why consider this job opportunity:
- Salary up to $208,900 annually
- Opportunity for career advancement and professional development
- Supportive team environment that values contributions and fosters creativity
- Comprehensive benefits package, including rewards and recognition programs
- Engage in meaningful work that contributes to advancing healthcare solutions
- Opportunities for on-site collaboration and flexible work arrangements

What to Expect (Job Responsibilities):
- Coordinate and conduct quality system audits to ensure compliance with regulations and corporate policies
- Establish and lead audit teams composed of qualified auditors
- Evaluate audit evidence against the approved Audit Action Plan (AAP)
- Maintain the audit system software database and provide periodic reports to management
- Collaborate with management to address inadequate AAP documentation when necessary

What is Required (Qualifications):
- B.S. degree in Engineering, Chemistry, Biology, or equivalent discipline; advanced degree preferred
- Minimum of 10 years of experience in the Quality organization of a medical device or pharmaceutical company
- At least 5 years of experience auditing compliance with domestic and international regulations for medical devices or pharmaceuticals
- Certification as a Certified Quality Auditor, ISO Lead Auditor, or equivalent
- Extensive knowledge of medical device regulations and standards, including FDA QSR and ISO 13485

How to Stand Out (Preferred Qualifications):
- Exemplar Global ISO 13485 Lead Auditor Certification or equivalent
- Experience with warning letters and other regulatory actions
- Advanced knowledge of other international medical device regulations (e.g., China, Saudi Arabia, Korea)
- Demonstrated ability to collaborate effectively with all levels of management
- Strong analytical and project management skills

#MedicalTechnology #QualityAssurance #CareerGrowth #CompetitiveSalary #HealthcareInnovation

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