Quality Analyst - FDA Reg Manufacturing

Are you passionate about ensuring the safety and efficacy of medical products? Do you have a keen eye for detail and a strong understanding of FDA regulations? If so, we have an exciting opportunity for you to join our team as a Quality Analyst for FDA Regulated Manufacturing at Mayo Clinic.As a Quality Analyst, you will play a critical role in maintaining the high standards of quality and compliance within our FDA-regulated manufacturing operations. Your expertise and attention to detail will be essential in ensuring that our medical products meet all regulatory requirements and are safe for our patients.To be successful in this role, you must have a strong understanding of FDA regulations and quality systems, as well as excellent analytical and problem-solving skills. Additionally, you should possess strong communication and interpersonal skills, as you will collaborate with various teams and stakeholders to ensure compliance and address any quality issues.Join us at Mayo Clinic and make a meaningful impact in the healthcare industry while advancing your career in quality assurance. Apply now and become a part of our dedicated team of professionals.

1. Conduct thorough reviews and analysis of all manufacturing processes, procedures, and documentation to ensure compliance with FDA regulations and company quality standards.
2. Monitor and track all changes and updates to FDA regulations and guidelines, and implement necessary changes to maintain compliance.
3. Collaborate with cross-functional teams to identify and address any quality issues and implement corrective and preventive actions.
4. Conduct audits of manufacturing facilities and processes to ensure compliance with FDA regulations and company quality standards.
5. Develop and maintain quality assurance procedures and policies, and provide training to employees on FDA regulations and quality systems.
6. Investigate and resolve any non-conformances or deviations from FDA regulations, and provide recommendations for improvement.
7. Maintain accurate and detailed records of all quality assurance activities and communicate any issues or concerns to management.
8. Stay up-to-date on industry trends and best practices in FDA regulations and quality systems.
9. Participate in regulatory inspections and audits, and assist in responding to any findings or observations.
10. Communicate and collaborate with external stakeholders, including FDA representatives, to ensure compliance and maintain positive relationships.
11. Conduct risk assessments and develop risk management strategies to ensure the safety and efficacy of all medical products.
12. Continuously review and improve quality processes and procedures to enhance efficiency and effectiveness.
13. Serve as a subject matter expert on FDA regulations and quality systems, providing guidance and support to other team members.
14. Uphold the company's commitment to patient safety and product quality through strict adherence to FDA regulations and company standards.
15. Contribute to the development and implementation of new quality initiatives and projects to drive continuous improvement in FDA-regulated manufacturing operations.

According to JobzMall, the average salary range for a Quality Analyst - FDA Reg Manufacturing in Rochester, MN, USA is $50,000-$80,000 per year. This may vary depending on the specific company, experience level, and other factors.

The Mayo Clinic is an American not-for-profit organization academic medical center based in Rochester, Minnesota, focused on integrated clinical practice, education, and research. It employs over 4,500 physicians and scientists, along with another 58,400 administrative and allied health staff.