Quality Assurance Specialist

3 weeks ago


Houston, United States Healgen Scientific Limited Full time
Job DescriptionJob Description

JOB TITLE: QUALITY ASSURANCE SPECIALIST

DEPARTMENT: QUALITY

SUPERVISOR: QA SUPERVISOR

1 PURPOSE

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.

2 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 as assigned by the QA Supervisor.


3 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.




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