Monica Burt & Associates
Job Description
MB&A, a recruiting and consulting firm specializing in the medical device manufacturing industry, is seeking a qualified Contract Quality Engineer to join our team in Memphis, TN. This position is designed for a skilled professional who is dedicated to ensuring the highest standards of quality in the production of medical devices. The successful candidate will work on a contract basis, contributing their expertise to support quality assurance initiatives.
Key Responsibilities:
Requirements
MB&A, a recruiting and consulting firm specializing in the medical device manufacturing industry, is seeking a qualified Contract Quality Engineer to join our team in Memphis, TN. This position is designed for a skilled professional who is dedicated to ensuring the highest standards of quality in the production of medical devices. The successful candidate will work on a contract basis, contributing their expertise to support quality assurance initiatives.
Key Responsibilities:
- Quality Assurance: Implement and maintain quality assurance processes to ensure compliance with industry standards and regulations in the medical device manufacturing sector.
- Risk Management: Collaborate with cross-functional teams to identify, assess, and mitigate risks associated with manufacturing processes and product quality.
- Documentation: Create and review quality documentation, including standard operating procedures, work instructions, and quality records, ensuring accuracy and compliance.
- Audits and Inspections: Conduct internal audits and support external audits to verify compliance with quality management systems and regulatory requirements.
- Continuous Improvement: Participate in continuous improvement initiatives to enhance product quality, operational efficiency, and overall effectiveness of the quality management system.
- Root Cause Analysis: Investigate and address non-conformities and customer complaints, conducting thorough root cause analyses and implementing corrective and preventive actions.
- Collaboration: Work closely with cross-functional teams, including manufacturing, engineering, and regulatory affairs, to ensure seamless integration of quality processes.
Requirements
- 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).