Quality Assurance Associate

Quality Assurance Associate – Oakland/Allendale, NJ

This position does not offer sponsorship now or in the future.

The Quality Assurance Associate will be responsible for batch records review and release for receiving, in-process and finished products and will maintain quality systems and related documentation as per current FDA regulations and ISO 13485 standards. This position ensures that the solid execution of company programs remain consistent with the overall company values. The ideal candidate has a solid understanding of the QA process and can support the strategic and operational objectives of the business.

The successful candidate will possess a high degree of professionalism, maturity and confidentiality.

• Identify and record any problems relating to the product, process and quality system.
• Review the accuracy of and maintain records directly related to the manufacture, inspection, or testing of products.
• Review verification activities for receiving, in-process and finished products to ensure that they are performed according to standard operating procedures.
• Maintain quality records in accordance with documented procedures.
• Release/quarantine in-process materials based on inspection or test results.
• Initiate, recommend or provide solution(s) through designated channels.
• Qualify personnel to perform specific quality assurance tasks.
• Initiate action(s) to correct or prevent the occurrence of any nonconformities relating to product, process or the Quality Management System
• Recommend Material Review Board meeting, if appropriate.
• Assist with various special ad hoc projects and other duties as assigned

• Bachelor's Degree or equivalent work experience in the biological sciences or engineering.
• Ability to follow written and oral instructions with minimum supervision.
• Familiar with batch record review/release documentation processes
• Familiar with packaging and labeling requirements for medical devices
• Familiar with cGMP, Good Documentation Practices, and quality systems
• Effective communication skills, both verbal and written reports.
• Experience in a medical device or science related field is a plus