Regulatory Compliance Expert

1 week ago


Memphis, Tennessee, United States Monica Burt & Associates Full time
Job Overview

We are seeking an experienced Contract Quality Engineer to join our team at Monica Burt & Associates in Memphis, TN. In this role, you will be responsible for ensuring the highest standards of quality in the production of medical devices.

Main Responsibilities:
  • Develop Quality Processes: Design and implement quality assurance processes that meet industry standards and regulations.
  • Manage Risk: Collaborate with cross-functional teams to identify, assess, and mitigate risks associated with manufacturing processes and product quality.
  • Create Quality Documentation: Develop and review quality documentation, including standard operating procedures, work instructions, and quality records.
  • Audit and Inspection: Conduct internal audits and support external audits to verify compliance with quality management systems and regulatory requirements.
  • Lead Continuous Improvement: Participate in continuous improvement initiatives to enhance product quality, operational efficiency, and overall effectiveness of the quality management system.
  • Investigate Non-Conformities: Investigate and address non-conformities and customer complaints, conducting thorough root cause analyses and implementing corrective and preventive actions.
Education and Experience
  • Bachelor's degree in Engineering or a related field.
  • Proven experience in quality engineering within the medical device manufacturing industry.
  • Knowledge of relevant regulations, such as ISO 13485 and FDA requirements.
  • Strong analytical and problem-solving skills, with the ability to conduct thorough root cause analyses.
  • Excellent communication and interpersonal skills to collaborate with diverse teams effectively.
  • Detail-oriented with a commitment to maintaining high standards of quality.
  • Ability to work independently and efficiently in a contract capacity (20-30 hours per week).

Estimated salary: $85,000 - $110,000 per year, depending on experience and qualifications.



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