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TRC Talent is looking for a Quality Analyst!
SUMMARY
As a Quality Analyst, you will play a crucial role in maintaining compliance with medical regulations and ensuring the quality of our products and processes. You will work autonomously while liaising with hourly associates and collaborating with teams in Kennesaw and France, as well as external consultants and Executive Leadership. This position requires a sharp, solution-focused mind and a professional communicator who can adapt to consistent changes in the work environment.
RESPONSIBILITIES
- Ensure the documentary management of the QMS:
- Participate in the definition of the quality standards that the Group sets for itself.
- Coordinate the drafting of policies and procedures accordingly with the validation of management.
- Ensure that the QMS meets the needs of the company and the requirements of the customers.
- Determine QMS monitoring tools.
- Ensure implementation of policies and procedures:
- Effectively communicate to all stakeholders about QMS policies and procedures.
- Train and/or organize training when necessary.
- Monitor and identify opportunities for improvement to bring QMS to life and align with business needs and practices.
- Monitor compliance of our processes with the QMS and Quality incident and CAPA management:
- Detect, investigate, report, manage incident issues.
- Ensure corrective and preventive actions are defined and implemented in collaboration with managers.
- Detect deviations from QMS and ensure corrective and preventive actions are in place.
- Effectively document compliance.
- Follow up on action plans to close compliance gaps with management and report to the VP of Global Operations.
- Coordinate operational licenses and certifications:
- Coordination and follow-up of the licensing process.
- Management of the documents and application to obtain and maintain the license
- Participate in internal audits to identify gaps and follow up on action plans with appropriate managers.
REQUIRED QUALIFICATIONS
- 3-5+ years of experience in Medical Quality Assurance.
- Preferred Master’s degree in a related field or equivalent experience
- Ability to work autonomously and make informed decisions.
- Strong analytical skills with a focus on problem-solving.
- Excellent communication skills, both written and verbal.
- A collaborative mindset with a willingness to adapt and grow within the department.
*If you are interested in this position and feel you meet the requirements, please apply and call 770-919-8405.
TRC Talent Solutions is proud to be an Equal Opportunity Employer (EOE). All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, protected veteran status, disability status, sexual orientation, gender identity or expression, marital status, genetic information, or any other characteristic protected by law.
