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Form of workJob Description
Plan and perform independent audits to evaluate and determine customer’s quality systems and/or products compliance to applicable standards and regulatory requirements.
PRINCIPAL DUTIES AND 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
QUALIFICATIONS & 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.
Certifications
- Commodity approved ISO 9001, ISO 14001, and ISO 4500 Lead Auditor Certification
SUPERVISORY REQUIREMENTS
- Direct: None
- Indirect: None
- Office, manufacturing and laboratory environments.
Equipment Used:
- Laptop Computer
Travel Required:
- Ability to travel up to 100% of time, both domestically and internationally.
TUV Rheinland North America EEO Statement
As a global business, TUV Rheinland North America relies on diversity of culture and thought to deliver on our goal of Creative People, Practical solutions serving our client needs, and ensures nondiscrimination in all programs and activities in accordance with Title VI and VII of the Civil rights Act of 1964. We continuously seek talented, qualified employees in our world-wide operations regardless of race, color, sex/gender, including gender identity and expression, sexual orientation, pregnancy, national origin, religion, disability, age, marital status, citizen status, protected veteran status, or any other protected classification under country or local law. TUV Rheinland North America is proud to be an Equal Employment Opportunity/ Affirmative Action Employer/ Federal Contractor desiring priority referrals of all protected veterans for job openings.
