Job details
Job type full-time
Full job description
Summary:
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 proceduresMay 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
Supervisory requirements
Direct:
Indirect:
Physical demands & work environment:
Office, manufacturing and laboratory environments
Equipment used:
Laptop/computer
Travel required:
Ability to travel up to 50 - 70% of time, both domestically and internationally
This job description is not intended to be all-inclusive and is not an exhaustive list of all required responsibilities, duties, and skillsThis description may be amended at any time and employee may be assigned other related duties to meet the ongoing needs of the organization.
