Quality Auditor - Alabama, United States - LHH

Description

LHH Recruitment Solutions is seeking a Quality Auditor in Birmingham, Alabama. The ideal candidate will conduct audits, inspections, and assessments to identify areas for improvement and ensure adherence to FDA regulations. This is an excellent opportunity for a detail-oriented professional with a strong background in medical manufacturing and FDA experience to contribute to our company's success.

Details:

• Onsite M-F
• Salary 80-90k with 10% bonus
• Will provide relocation
• Must have Medical or FDA experience
• Must have experience doing internal audits

Key Responsibilities:

• Conduct internal and external audits to assess compliance with FDA regulations and company quality standards.
• Perform inspections and reviews of manufacturing processes, documentation, and procedures to ensure adherence to quality requirements.
• Identify areas for improvement and recommend corrective actions to address non-conformities.
• Maintain audit records, documentation, and reports in accordance with regulatory requirements.
• Collaborate with cross-functional teams to implement quality improvements and ensure continuous compliance with regulatory standards.
• Provide training and guidance to staff on quality systems and regulatory requirements.
• Stay up-to-date on changes in FDA regulations and industry best practices related to medical manufacturing.

Qualifications:

• Minimum of 2 years of experience in FDA-regulated medical manufacturing environment.
• Proven experience conducting audits and inspections in accordance with FDA regulations.
• Strong knowledge of FDA regulations, including 21 CFR Part 820 and ISO 13485.
• Excellent attention to detail and analytical skills.
• Effective communication and interpersonal skills.
• Ability to work independently and collaboratively in a fast-paced environment.

Education:

• Bachelor's degree in a related field preferred.