Quality Manager

About the role

The Quality Manager will be responsible for ensuring that refurbished medical devices and equipment meet all necessary quality and 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, training, 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. 

Key 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 control of and documentation for all quality processes, audits, and certifications. 
• 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. 

Qualifications

• Bachelor’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 9001 & 13485 certification, and other relevant medical device regulatory requirements experience highly preferred. 
• 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:  On Site. Monday to Friday 

Salary Range: $90-$95,000