- Plan and perform independent audits to evaluate and determine customer’s quality systems and/or products compliance to applicable standards and regulatory requirements.
- 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.
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.
- Bachelor’s Degree in an Engineering or Life Science discipline or equivalent education and/or 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