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Job Description
Quality Engineer position available for immediate start. Collaborate with Project Managers, Design Engineers, and clients to establish compliant product specifications. Ensure quality review of process validation plans, protocols, and reports. Coordinate and contribute to product risk management file generation and maintenance. Manage lot records, testing, and release of sterilized products. Review SOPs, work instructions, and quality standards. Perform root cause analysis, disposition, and corrective action of non-conformances. Support customers in product submissions to regulatory authorities. Conduct internal audits and audits preparation. Maintain and develop QMS for medical device manufacturing environment.