Quality Auditor - Birmingham, United States - LHH Recruitment Solutions

Description

The successful candidate will significantly impact the company's Quality System regulations and standards for quality audits and supplier compliance. They will shape suppliers and regulators perceptions of competence in responsiveness to information requests and regulatory compliance.

Responsibilities:

• Ensure compliance with regulatory requirements by adhering to the company's Quality Management System.
• Establish, document, and maintain the company's internal audit program, scheduling audits to evaluate compliance with regulatory standards such as ISO 13485, 21 CFR, EU MDD/EU MDR, and MDSAP.
• Define, document, and improve the Quality System by establishing minimum policy requirements and controlled documents.
• Conduct on-site audits according to the agenda, including audit closeout.
• Prepare audit reports promptly as per standard operating procedures.
• Issue internal audit corrective action requests and monitor effectiveness.
• Analyze internal audit data and track timeliness trends.
• Document, release, and communicate changes to internal audit quality assurance policies and procedures as needed.
• Assist with the supplier quality audit program as directed.
• Participate in professional development and training to attain necessary certifications.
• Implement and maintain electronic quality management system software for tracking audit corrective actions.

Qualifications:

• Desired experience with electronic quality management system software
• Excellent verbal and written communication skills
• Strong planning and organizational abilities with attention to detail
• Capacity to prioritize tasks and manage multiple responsibilities within deadlines
• Proficiency in Microsoft Office Suite
• Bachelor's Degree required; graduate degree preferred
• 2 years of auditing experience in an FDA-regulated environment
• Experience in a regulated industry with exposure to Quality Assurance and/or Internal Audit programs
• Experience in an FDA-regulated environment using technical specifications and documentation

Pay Details: $80,000.00 to $88,000.00 per year

Search managed by: Pamela Franco

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.