Quality Manager

About Us: Active Protective Technologies is a medical device startup committed to revolutionizing fall injury prevention and improving the lives of older adults. Our flagship product, the Tango Belt, integrates cutting-edge technology into a wearable device to mitigate fall-induced major hip injuries, a leading cause of disability and fatal injury in older adults. The Tango Belt was designated a Breakthrough Device by the FDA to recognize its potential to significantly improve the standard of care for this debilitating condition. For more info on our mission and product, please visit www.tangobelt.com.

Job Overview: Active Protective seeks a Quality Manager with both industry-standard technical skills and an attitude to contribute, in a collaborative, positive work environment, who can help take our Quality system to the next level. The Quality Manager will be responsible for overseeing and managing the quality assurance and quality control processes, driving continuous improvement initiatives, and managing Quality employees.

Key Responsibilities:

• Quality Management Systems: Develop, implement, and maintain quality management systems (QMS) in compliance with relevant regulatory requirements (e.g., ISO 13485, FDA 21 CFR Part 820). Ensure that processes are effectively documented, executed, and audited.
• Quality Assurance: Oversee quality assurance activities, including the development of quality plans, inspection and testing procedures, and quality control measures. Ensure that products meet predefined quality criteria before release. Perform and manage non-conformance investigations, as needed.
• Continuous Improvement: Lead continuous improvement initiatives to enhance product quality, reduce defects, and increase efficiency. Analyze quality metrics and trends to identify areas for improvement and implement corrective and preventive actions. Perform and manage CAPA investigations under direction.
• Supplier Quality Management: Manage and assess supplier quality, including overseeing supplier role in design and change projects, conducting audits, evaluating performance, and ensuring that supplier processes and products meet quality standards. Perform and manage SCAR under direction.
• Training and Development: Develop and deliver quality training programs for employees to ensure understanding and adherence to quality standards and procedures. Promote a quality-focused culture across the organization.
• Documentation and Reporting: Maintain accurate and comprehensive quality documentation, including records of inspections, audits, and corrective actions. Prepare and present regular quality reports to senior management.
• Customer Complaints: Investigate and resolve customer complaints related to product quality. Implement corrective actions and preventive measures to address root causes and prevent recurrence.
• Manufacturing: Support in-house manufacturing as needed to ensure it meets GMP and consistently produces quality products.
• Design & Development: Support new product development and changes to product by offering design-for-quality input and ensuring design team follows established processes.
• Metrology: Maintain proper calibration on all quality inspection tools. Assist in maintaining calibration on manufacturing tools, as requested.
  
  

RequirementsQualifications:

• Education: Bachelor’s degree in Engineering, Life Sciences, Quality Management, or a related field. A Master’s degree or professional certification (e.g., CQE, CQA) is preferred.
• Experience: Minimum of 5-7 years of experience in quality management within the medical device industry. Demonstrated experience with quality management systems.
• Personal Skills: Strong communication skills, both written and verbal. Strong ability to work collaboratively with team-members, and to work under business direction.
• Technical Skills:
• Strong knowledge of quality management principles (ISO 13485).
• Excellent problem-solving and analytical skills.
• Strong attention to detail and commitment to maintaining high quality standards.
• Proficiency in quality management software and tools.
• Effective communication and interpersonal skills.
• Knowledge: In-depth understanding of medical device manufacturing processes, quality assurance practices, and industry standards.