Quality Manager
4 weeks ago
About AA MedicalAA Medical is a provider of sustainable solutions to both the new and resale medical device equipment markets. AA Medical was founded in 2012 to help doctors and surgeons around the world access high quality pre-owned medical equipment at an affordable price. We are proud to consistently connect the world with life sustaining medical equipment and are constantly working towards even more growth.AA Medical offers a variety of benefits to ensure that our employees feel supported and valued. Here's a summary of what we offer:-Unlimited PTO for exempt employees, so you can take the time you need to recharge and enjoy life outside of work.-4 paid mental health days to prioritize your mental wellness.-9 observed holidays to spend time with loved ones and celebrate important occasions.-Medical coverage with HSA and PPO options, so you can choose the plan that works best for you.-FSA and HSA accounts, as well as dependent care FSA, to help you save on healthcare and dependent care expenses.-Discounts on pet insurance to keep your furry friends healthy.-Delta Dental and Delta Vision insurance offerings.-Short term and long term disability coverage through Principal, to provide financial protection in case of unexpected events.-EAP (employee assistance program) through Principal, to provide confidential support and resources for personal and work-related challenges.-Pet friendly office in Mokena, to make your furry friends feel welcome and at home.-4% 401(k) company matchAbout the roleThe Quality Manager will be responsible for ensuring the refurbished medical devices meet all necessary regulatory standards, including FDA and ISO certifications. This role is central to maintaining and improving the quality management systems (QMS) that ensure product quality, safety, and compliance. The Quality Manager will lead audits, monitor quality performance, and collaborate with cross-functional teams to meet regulatory requirements and ensure the highest standards of product integrity, while also ensuring a best of class EHS program. What you'll doKey Responsibilities: Ensure that the company complies with all relevant regulations, including FDA (Food and Drug Administration) standards and ISO 13485 requirements for medical devices. Develop, implement, and maintain the Quality Management System (QMS) to meet FDA and ISO requirements for refurbished medical devices. Lead internal and external audits, including FDA inspections and ISO certification audits, ensuring that all processes are documented, and any corrective actions are completed promptly. Collaborate with Acquisitions and Distribution Operations teams to ensure appropriate process and quality controls around incoming materials. Oversee the inspection, testing, and validation processes of refurbished medical devices to ensure compliance with quality and safety standards. Ensure that the organization maintains and adheres to appropriate packaging and shipping processes to ensure delivery of quality products to AA's customers. Oversee the organization's RMA process to include Sales Ops appropriate issuance of RMAs, investigation and classification of returned materials, issuance of CAPAs, and report out of results. Management of corporate EHS program for all sites. Maintain comprehensive and detailed documentation for all quality processes, audits, and certifications. Collaborate with suppliers to ensure that all incoming materials meet quality standards and work with them to resolve any quality issues. Investigate any quality-related issues, perform root cause analysis, and implement corrective and preventive actions to avoid recurrence. Develop and oversee training programs and guidance to employees on quality standards, procedures, EHS, and regulatory compliance. Lead continuous improvement initiatives and Kaizen events to enhance product quality and operational efficiency. QualificationsBachelor's degree in Engineering, Life Sciences, or related field (advanced degree preferred). Minimum of 5 years of experience in quality management, preferably in the medical device industry or refurbished medical device sector. Strong understanding of FDA regulations, ISO 13485 certification, and other relevant medical device regulatory requirements. Proven track record in conducting and leading audits, including FDA and ISO inspections. Excellent analytical skills with experience in root cause analysis and corrective action processes. Strong verbal and written communication skills, with the ability to interact effectively with internal teams, suppliers, and regulatory bodies. High level of accuracy and attention to detail in managing quality systems and documentation. Certification in Quality Management (such as CQE or CQA) or experience with Six Sigma methodology is a plus. Schedule: Monday to Friday
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