What are the responsibilities and job description for the Certified Quality Auditor position at Monica Burt & Associates?
Job Description
MB&A, a recruiting and consulting firm specializing in the medical device manufacturing industry, is currently seeking a Certified Quality Auditor for a short-term contract position. The ideal candidate will be an experienced professional with a strong background in quality auditing, particularly in compliance with ISO 13485 standards. This role requires a commitment to excellence, a keen eye for detail, and a willingness to travel to client locations as needed.
Key Responsibilities :
- Quality Audits : Conduct thorough audits of quality management systems, processes, and documentation to ensure compliance with ISO 13485 standards and other relevant regulations.
- Report Generation : Prepare detailed audit reports outlining findings, observations, and recommendations for corrective actions.
- Compliance Verification : Ensure that all aspects of the medical device manufacturing process adhere to industry standards, regulatory requirements, and company policies.
- Root Cause Analysis : Collaborate with cross-functional teams to identify root causes of non-conformities and assist in the development and implementation of corrective and preventive actions.
- Documentation Review : Assess and validate quality documentation, including standard operating procedures, work instructions, and quality records.
- Travel : Be willing to travel to client locations as required to perform on-site audits.
Requirements
Qualifications :