Quality Assurance Specialist - Houston, United States - Healgen Scientific Limited

Healgen Scientific Limited

Verified Company

Houston, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

JOB TITLE:

QUALITY ASSURANCE SPECIALIST

DEPARTMENT:

QUALITY

SUPERVISOR:

QA SUPERVISOR
1 PURPOSE

2 DUTIES AND RESPONSIBILITIES

Work with a crossfunctional team to ensure all documents are properly stored and archived.
Support and track Quality related events such as CAPAs, SCARs, Nonconformances, 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 inprocess and finished products.
Assist manufacturing with batch release and other relevant documentation.
Assist with postmarket 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 crossfunctional 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 daytoday tasks
Preference for bilingual individuals that can speak and write Chinese or Spanish.