Quality Assurance Specialist (Non-Software)
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 Specialist develops, establishes and maintains Document Control methodologies, systems and practices which meet the applicable regulatory requirements and procedures. Independently performs in-coming, in-process, and final inspection of components and systems. Improves Document Control, Training, Investigations and Good Documentation Practices (GDP), awareness of the regulatory and quality requirements to the different functional areas. Communicates quality initiatives in support of departmental, functional quality goals and priorities. Provides Document Control, Training support to the Quality and R&D teams, as needed. Administers any applicable company investigation systems (ex. CAPA, OOS, Deviations). This is a hands-on position.
- Independently performs in-coming, in-process, final inspection of components and systems using inspection and measurement tools like a caliper.
- Comfortably uses sampling methods (Z1.4/Z1.9) to support visual and functional inspections.
- Champions Document Control, Investigations and Training initiatives.
- Authors, revises, reviews, formats AMERICAN PAPR documentation in compliance with company procedures and the applicable regulatory requirements and standards.
- Manages and maintains the Document Control and Training system which includes the organization, issuance, maintenance, archiving and retirement of documents.
- Maintains internal and external documentation libraries and is the primary liaison for external libraries subcontractors.
- Ensures that all documentation is controlled and current.
- Ensures that all employee training is conducted and documented in compliance with all the applicable procedures.
- Generates applicable training materials including: Document Controls, Training, Investigations, GDPs, and other materials as needed and defined in the Procedures manual. Conducts related trainings periodically/as needed.
- Provides guidance and support to teams in generating applicable documentation.
- Proactively investigates document control issues, identifies improvements and implements good documentation practices.
- Ensures that all applicable Quality requirements are met at all stages of the product development process and manufacturing.
- Manages Employee Training documentation including the maintenance of employee training records.
- 2-3 years experience in a manufacturing regulated company (aerospace, automotive, medical device) and/or Bachelor's in engineering/ life sciences, or a related field. Degree requirement is waived for applicants with 6 or more years of relevant experience.
- Working knowledge of Good Manufacturing Practices (GMPs).
- Ability to prioritize, manage time well, multitask, troubleshoot.
- Basic knowledge of US Quality System Regulatory requirements.
- Ability to effectively communicate with a broad spectrum of people having varying backgrounds, education, and experience.
- Demonstrated success in delivery of key milestones against tight timelines.
- Aptitude to succeed in the culture of a fast-paced, start-up medical equipment company.
- Strong written and verbal communication skills; Technical writing skills preferred.
- Strong organizational and computer (Microsoft Word, Excel, Powerpoint, Adobe Acrobat) skills required.
- This is a full-time position based in Brooklyn, NY
- The Quality Assurance Specialist will report directly to the Senior QA/QC specialist (or Head of Quality).
- Must be able to work in a team environment and with minimal supervision
- Ability to occasionally lift 25lbs.