Associate Manager managing Stryker’s Quality Management System and coordinating quality assurance tasks. Ensuring compliance with ISO standards and supporting audits.
Responsibilities
Manage and maintain Stryker’s Quality Management System.
Support internal and external audits.
Ensure processes meet ISO 9001 and ISO 13485 standards.
Coordinate quality assurance tasks, including auditing and certification processes.
Administer and implement the Quality Management System (CAPAs, deviations, change control, risk analysis, document control, complaints).
Execute internal audits and participate in external audits, following up on corrective actions.
Develop and implement continuous improvement programs focused on efficiency and regulatory compliance.
Manage and monitor warehouse processes from a quality perspective.
Implement local, regional, or global processes as required by the quality system.
Monitor key performance indicators (KPIs) and manage field action, product retention, and recall processes.
Requirements
Required Bachelor’s degree in Engineering or a related field.
3 to 5 years of experience in quality assurance and quality management functions.
Experience in the medical device industry and other regulated environments.
Proven experience with Quality Management Systems based on ISO 9001 and ISO 13485.
Experience as a lead auditor.
Advanced English.
Proficiency in Microsoft Office.
Preferred Experience with quality management tools and ERP systems (Trackwise or similar).
Tester mobilních aplikací specializující se na interní vývoj a testování pro zákaznické aplikace E.ONu. Pracujte v týmu v Českých Budějovicích, Praze nebo Brně.
Customer Care Quality Assurance Officer evaluating customer interactions and improving quality standards at Allianz. Collaborating with teams to enhance customer service through data - driven insights.
Associate Director Clinical QA Compliance ensuring quality and integrity of clinical development activities at BioNTech. Leading the proactive, risk - based Quality Strategy implementation across clinical trials.
QA Manager role at Perrigo ensuring product quality through oversight of manufacturing and packaging. Focusing on cross - functional continuous improvement and regulatory compliance in the pharma sector.
Officer, QA (Oncology) at Hikma Pharmaceuticals conducting analytical research and ensuring product compliance. Collaborating in a culture of progress in the pharmaceutical industry in Algiers.
Quality Engineer at Hikma Pharmaceuticals creating control groups and qualifying inspectors. Leading QA initiatives and auditing processes to ensure compliance and continuous improvement.
Ingénieur QA R&D travaillant sur l'amélioration continue de la qualité logiciel. Collaborer avec les équipes de développement agile et participer à la conception et automatisation des tests.
Quality Assurance Coordinator at Aveanna Healthcare assisting in maintaining client files and compliance. Participating in audits and quality assurance training programs while adhering to company values.
Quality Assurance Associate supporting and maintaining Quality Systems for a comprehensive laboratory services organization. Engaging in document control, internal audits, and training support while overseeing compliance with regulatory requirements.