Quality Assurance Specialist
Quality Assurance | Kinderhook , NY
Join us on our exciting journey!

Healgen Scientific is a global leader in developing, manufacturing and commercializing In-Vitro Diagnostic test systems. Since our inception in 2007, we have strived to develop devices that meet and exceed industry standards. Our comprehensive portfolio of high quality, tailored solutions span multiple testing categories and analytes to meet various clinical and laboratory needs. Our products include rapid visual tests, digital point of care (POC) devices, molecular diagnostics, and multiplex flow cytometry.

Please send your resumes hr@healgen.com

About the role

Quality Specialists ensure that products and services produced meet the desired quality standards. Their responsibilities include developing and implementing quality control procedures, monitoring product performance, and identifying and addressing quality issues.

Responsibilities

Inspection of incoming raw materials, in-process, and finished products.

Assist manufacturing with batch release and other relevant documentation.

Assist with post-market monitoring of the company’s products.

Assist with training as required.

Assist with maintaining equipment calibration logs and temperature and humidity monitoring in the warehouse and manufacturing area.

Assist with maintaining proper documentation of incoming and outgoing products.

Facilitate the periodic review of documents to comply with internal QMS requirements.

Ensure completed documentation meets internal quality standards.

Support the Internal Quality Audit and External Audits at the facility.

Manage relevant record logs for Quality Events; Work on CAPA, SCAR, and deviation, as required.

Assist in other duties as assigned by the Senior QA Manager.

Qualifications

Have at least 4-5 years of relevant experience and a relevant bachelor’s degree OR at least 8-10 years of relevant experience without a degree, preferably in the Medical Device industry.

Be able to work with a cross-functional team on an international stage.

Be able to communicate effectively in written and spoken English.

Be able to troubleshoot as necessary.

Be able to prioritize tasks effectively.

Show initiative and be proactive in their day-to-day tasks.