Quality Systems Specialist - Garden City, NY

Quality Systems Specialist

 

Reports to:     Director, Quality                                            Location:        Garden City, NY

 

Job Summary

Quality Systems Specialist will contribute to a passionate and collaborative Quality Assurance team to enable the overall success of our QMS. In this role, you will support the maintenance of Quality Systems including CAPAs, Nonconformances, Audits, Quality Metrics and Analytics, and continuous improvement activities.

 

Accountabilities

  • Responsible for support management and tracking of quality records (i.e., CAPA’s, Audits, Nonconformances, Effectiveness Checks and Change Controls)
  • Develop and deliver training in quality systems topics (i.e., configuration changes to the electronic QMS system).
  • Support management review process through development and generation of quality system metrics and trending; escalate issues as required.
  • Author/revise/approve standard operating procedures (SOPs) and other GMP documents as needed.

Activities

  • Responsible for support management and tracking of quality records (i.e., CAPA’s, Audits, Nonconformances, Effectiveness Checks and Change Controls)
  • Provide oversight of open quality records, collaborating closely with internal customers to ensure compliance and timeliness. Provide support and guidance as needed.
  • Identify and drive opportunities for enhancement to existing quality systems/tools to achieve improved quality performance.
  • Participate in and support FDA Inspection Readiness activities, including participation in regulatory inspections, as needed.
  • Actively assuring compliance to ISO13485, EU-MDR 2017/745 & 21 CFR part 820.
  • Actively participate and provide guidance in additional quality topics, as needed, including risk management, training, and quality culture excellence.
  • Collaborate with a broad range of internal customers (Supply Chain, Quality Assurance, Quality Engineering, Regulatory Affairs, Clinical Affairs, Engineering, Operations).
  • Work hands-on with all aspects of Quality and Regulatory documentation within 21 CFR 820 (Quality System Regulation, Medical Device)
  • Assist with categorizing (including assigning designated approvers) and updating file names within the eQMS to ensure ease-of-use for retrieving documentation.
  • Retire or obsolete eQMS documents as applicable
  • Identify compliance/non-compliance with procedures and resolves necessary amendments to the Quality System and GMP documentation
  • Ensure job descriptions, resumes and certifications for new employees are up-to-date
  • Coordinate the training of new employees and current employees to applicable Quality Procedures and GMP documentation
  • Develop training curriculum that adheres to Quality Procedures for authors with “edit permissions” within the eQMS
  • Provide administrative support for customer feedback process including documentation of information

 

Qualifications / Requirements/Experience

  • BS in a scientific or equivalent work experience. CQA or CQM/OE is a plus
  • 3+ years of experience working as a Quality Systems Specialist in FDA regulated medical device environment
  • Understanding of ISO 13485:2016 requirements and how to apply them to a QMS, including a broad knowledge of documentation control requirements.
  • Good communicator with excellent attitude and willingness to learn, grow and contribute in a fast-paced environment
  • Demonstrated experience with Microsoft office suite and Adobe Acrobat, including Excel, Word PowerPoint


EEO Statement:

Beyond Air is an equal opportunity employer and values diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

 

Headquartered in Garden City, New York, the company has locations in Madison, WI, Rehovot, ISR and Dublin, IRE. The Beyond Air leadership team has deep industry experience developing nitric oxide delivery systems. The team has decades of experience in bringing lifesaving medicines and devices to markets and patients around the globe. 

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