Description Quality Engineer - ISO and FDA - Healthcare refrigerators and warming cabinets The Quality Engineer will lead our growth and be responsible for implementing an ISO13485 quality program, and FDA certification for a growing line of blood bank refrigerators, warming cabinets, incubators, and other medical devices. They will participate in setting company priorities and working with senior management to champion growth in manufacturing, sourcing, and operations, while maintaining quality standards.
This is a full-time, on-site role that can be based in either our Bronx, NY or Edison, NJ locations. Occasional travel between facilities may be required.
Responsibilities: - Implement an ISO13485 quality program and FDA certification for medical devices
- Maintain and help upgrade our ISO/IEC 9001: 2015 to the upcoming standard.
- Develop, review and maintain our quality manual, policies, objectives, procedures, work instructions and forms required to comply with ISO 9001:2015 and FDA requirements for Class II medical devices.
- Prepare for external audits and manage communication with third party certifying agencies and FDA during audits, inspections and investigations.
- Maintain all records of the Quality Management System and ensure they are accurate for external audits.
- Develop and maintain internal audit programs to proactively identify compliance issues or relevant changes to the QMS
- Review internal QC processes and coordinate with internal departments to ensure adherence to ISO requirements.
- Interface with Product Development, Engineering, Purchasing, and Logistics organizations to provide expert quality guidance.
- Work with our sourcing team to drive supplier quality performance.
- Support Operations facilities during customer and third-party audits and develop corrective actions as necessary.
- Create a positive working environment that encourages creative thinking and drives engagement.
- Other related duties as assigned
Your Qualifications: - 4 Year degree in Engineering, Statistics, Mathematics, or Project Management
- Minimum of 5 Years of Experience in Leading Quality and Project Management activities
- Minimum of 2 years of experience in Quality management of FDA Class II Devises, ISO 13045 or related fields
- ISO 9001 Lead Auditor Certification (Preferred)
- Strong technical background with Product Quality and Project Management with extensive experience in leading processes and teams
- Advanced knowledge/experience in Data Analytics.
- Ability to lead cross-functional teams.
- Able to take initiative and work interdependently, and collaborate with teams
All full-time FSI employees receive: - Medical/Dental insurance (some employee contribution is required)
- Company paid vision and life insurance.
- Transit check and 125 medical plans.
- 401k with a company match.
- Paid vacation and sick time.
- Discretionary bonuses and profit sharing.
Salary: $90 to $120,000 commensurate with education and experience
Location: Bronx NY or Edison, NJ
Our Bronx location is convenient to public transportation and is close to most major highways with on-premise parking. Our Edison, NJ facility is convenient to the NJTP, GSP, I287 and NJ440 with ample parking. We have modern offices, a business casual dress policy and an operations-driven busy environment.
Pay RangeLocation HQ (Bronx)
This position is currently accepting applications. 
