Quality Assurance Specialist

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.

The ideal Quality Assurance Specialist candidate would have a strong understanding of FDA guidelines and ISO 13485 regulations to ensure compliance and uphold product quality standards. The Quality Assurance Specialist will play a critical role in the development, implementation, and maintenance of quality assurance processes and systems to support the manufacturing and distribution of medical devices.

Responsibilities

Work with a cross-functional team to ensure all documents are properly stored and archived.

Support and track Quality related events such as CAPAs, SCARs, Non-conformances, Deviations, Reworks and Customer Complaints.

Supports investigations and root cause analyses.

Facilitate document control and change control process by initiating and completing CO’s.

Coordinate with process owners to update procedures and draft documentation as required.

Ensure completed documentation meets internal quality standards.

Data entry and basic statistical analysis.

Support during Internal and External regulatory audits.

Inspection of raw material and in-process and finished products.

Assist manufacturing with batch release and other relevant documentation.

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

Creates and keeps track of training events to ensure employee training records are up to date and compliant.

Support with supplier evaluations and maintenance of the Approved Supplier List.

Assist in other duties as assigned by the QA Supervisor.

Qualifications

Have at least 2 years of relevant experience and a relevant bachelor’s degree OR at least 5 years of relevant experience without a degree, preferably in the Medical Device or Pharmaceutical 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.

Preference for bilingual individuals that can speak and write Chinese or Spanish.