American PAPR (a subsidiary of 3DBio) is a protective equipment manufacturer of Power Air-Purifying Respirators. Our FELIX™100 PAPR is NIOSH-approved under the Public Health Emergency for PAPR100-N protection (99.97% filter efficiency level) effective against particulate aerosols free of oils. And recently received full NIOSH certification under HE (high efficiency) designation for our second generation PAPR the FELIX200. The device(s) is manufactured and assembled in the USA within a medical equipment production facility operating under a comprehensive Quality System (QS). The FELIX™100-200 meets NIOSH requirements per 42 CFR Part 84 for respiratory protection against particulates.
The Quality Assurance Manager will manage all Quality System and Product Quality activities at American PAPR. The Manager designs, implements and manages the company’s quality management system (QMS) in compliance with US regulations and standards for Powered Air-Purifying Respirators (PAPR). The Quality Assurance Manager plans and executes activities related to all aspects of Quality Assurance and Quality Control.
- Lead and manage Quality Assurance and Quality Control activities to ensure that the final product is safe for use by customers and meets US regulations. ,.
- Ensures a safe manufacturing of the product while meeting the predetermined production goals.
- Manages the company QMS Document Control system per the company’s Quality Manual.
- Manages internal and Supplier Audits Program and auditing activities.
- Oversee the Supplier Management Program.
- Manages the Quality Control activities including In-coming, in-process and final inspection of the product.
- Manages the Calibration and Preventive Maintenance program and provides support to the manufacturing team.
- Fully participants in new product design reviews and production meetings.
- Review and approves new and updated product documentation which includes but not limited to SOPs, Inspection forms, Manufacturing Batch Records, Qualifications and Validations, Test Reports.
- Ensure the implementation and maintenance of Quality systems including: the compliance status of Change Control, Deviations, CAPAs, Investigations and the Document Control system.
- Provide Quality System metrics to senior leadership/executive management on a periodic basis as applicable. Assist in the development of new metrics.
- Recommend modifications to policies and procedures.
- Manages project completion schedules by prioritizing and leading Quality Projects.
- Identifies problems related to Quality and compliance and propose solutions.
- Initiate continuous improvement of quality systems and processes by identifying, proposing and implementing systemic changes.
- Manages Risk Management activities. Provide compliance support in determining risk mitigation for risks associated with Quality System processes.
- Assists in developing and maintaining training plans in coordination with the manufacturing manager.
- Manages a team of Quality Engineers (1-2 direct reports) with diverse focus and responsibilities in a highly demanding and dynamic manufacturing work setting
- Actively and Accurately Supports the Regulatory/Quality Directors with the company strategy and business objectives with respect to Quality Policy and regulation and ensures alignment with industry best practices.
- Support Quality strategic projects.
- Provides Quality input to the Research and Development team during new product launch meetings or routine product updates.
- Bachelor degree required; ASQ or is a plus.
- 5+ years of quality experience in a manufacturing company in a regulated industry like medical device, automotive, pharma, aerospace.
- Strong knowledge of US Quality System requirements. Familiarity with US regulation 42 CFR Part 84 and communicating with NIOSH is a plus.
- Strong Team-working and communication skills. A drive to get the job done.
- Self-directed and able to apply problem solving methodologies.
- Ability to achieve Company milestones.
- Ability to effectively communicate with a broad spectrum of people having varying backgrounds, education, and experience.
- Ability to act as a change agent and drive/influence change as well as effectively lead and motivate team members to achieve goals.
- Expert ability to deliver key milestones against tight timelines.
- Aptitude to succeed in a fast-paced, start-up medical equipment company.
- This is a full-time position based in Brooklyn, NY
- The QA Manager will report directly to the Director of QA or the Chief Scientist Officer (CSO).