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.