Remote Lead Auditor (Commodity Standards)

Role Description:

• Plan and perform independent audits to evaluate and determine customer’s quality systems and/or products compliance to applicable standards and regulatory requirements.

Responsibilities:

• Perform and document pre-audits, registration audits, re-audits and surveillance audits following relevant published standard(s), regulatory requirements and company procedures. May lead audit team and be responsible for successful accomplishment of assigned project.
• Review and forward audit reports, client responses to audit non conformities, and other technical documentation reports to Certification Specialist.
• Inform client management through verbal and written communication of compliance issues, relevant standards and regulatory requirements.
• Evaluate product nonconformance related to product processes and specifications.
• Establish and maintain strong professional relationships with customers.
• Maintain and expand technical expertise in specific product fields.
• Perform other duties as assigned.

Requirements:

Knowledge, Skill, & Abilities 

• Broad knowledge of domestic and international regulatory compliance laws and regulations, including specific product directives.
• Ability to read and interpret documentation for compliance with procedures, standards and regulations.
• Ability to communicate with client’s highly specialized engineers, scientists and regulatory employees.
• Must be highly organized and able to work independently.
• Technical expertise in product field
• Ability to travel domestically and internationally. Valid passport and driver’s license required.

Education 

• Bachelor’s Degree in an Engineering or Life Science discipline or equivalent education and/or experience.

Experience 

• 2 years of experience in conducting global regulatory compliance audits. 
• 4 years of experience in the product industry with at least 2 years experience in quality assurance or regulatory affairs. 
• Computer literacy required including Microsoft Office applications