The ideal QA 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.

Duties and 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.

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.