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Certified Quality Auditor

3 months ago

Memphis, Tennessee, United States Monica Burt & Associates Full time
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:

  1. Quality Audits: Conduct thorough audits of quality management systems, processes, and documentation to ensure compliance with ISO 13485 standards and other relevant regulations.
  2. Report Generation: Prepare detailed audit reports outlining findings, observations, and recommendations for corrective actions.
  3. Compliance Verification: Ensure that all aspects of the medical device manufacturing process adhere to industry standards, regulatory requirements, and company policies.
  4. 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.
  5. Documentation Review: Assess and validate quality documentation, including standard operating procedures, work instructions, and quality records.
  6. Travel: Be willing to travel to client locations as required to perform on-site audits.
Requirements

Qualifications:
  1. Bachelor's degree in a relevant field or equivalent combination of education and experience.
  2. Certified Quality Auditor (CQA) designation is required.
  3. Minimum of 5 years of experience in quality auditing within the medical device manufacturing industry.
  4. In-depth knowledge of ISO 13485 and other relevant quality management standards.
  5. Strong analytical and problem-solving skills, with attention to detail.
  6. Excellent communication and interpersonal skills.
  7. Flexibility and willingness to travel to client location for on-site audits.
  8. Ability to work efficiently within a 3-6 months contract timeframe.