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Senior Quality Assurance Manager
2 months ago
Position: Senior Quality Assurance Manager - Medical Devices
Location: Atlanta, GA
Work Environment: Onsite
Experience Level: Senior Level
Our client, a leading global organization in the medical device sector, is seeking a Senior Quality Assurance Manager for their manufacturing facility. This role is pivotal in overseeing all quality assurance processes to guarantee that products adhere to safety and efficacy standards. The company prioritizes a patient-centered approach in all operational decisions.
Key Responsibilities- Guide and develop the Quality Assurance team to improve personnel performance and refine inspection methodologies, promoting a culture of ongoing enhancement.
- Continuously evaluate and optimize quality assurance inspection methods and operational effectiveness.
- Manage the evaluation and approval of internal and external Non-Conformance Reports (NCRs), Corrective and Preventive Actions (CAPAs), and other Quality System inputs.
- Ensure prompt identification, documentation, and resolution of nonconforming materials throughout all product acceptance phases.
- Create and uphold comprehensive quality assurance inspection plans, tests, and methodologies, utilizing statistical approaches where relevant.
- Implement thorough training programs for employees to ensure skill proficiency.
- Monitor and report on departmental efficiency metrics and benchmarks.
- Review and authorize relevant Quality System documentation to ensure compliance.
- Encourage effective communication and collaboration across departments to enhance quality system execution.
- Bachelor's degree in a relevant field such as Science or Engineering.
- Over 5 years of experience in a medical device manufacturing setting, focusing on Quality Systems, Quality Assurance, or Quality Engineering.
- At least 3 years of leadership experience.
- Knowledge of ISO 13485, FDA, and EN regulations.
This role offers an opportunity to lead quality assurance initiatives in a dynamic environment focused on innovation and patient care.