Overview
Quality Specialist/Document Control Jobs in Irving, Texas, USA at Astura Medical
Position: Quality Specialist (Document Control)
Join to apply for the Quality Specialist (Document Control) role at Astura Medical
Description
Astura’s Quality Specialist (Document Control) will ensure the completion and maintenance of quality items and documents. This position will report to the Quality Assurance Manager.
Job Responsibilities
Maintaining the document control system to ensure storage of documents and accurate tracking
Proof-read Regulatory and Quality documents
Maintenance of Employee Training Records
Maintenance of open documents in EPDM System
Completion of NCMR and CFI reports
Completion of CAPAs and SCARs and necessary follow-ups
GUDID Submissions
Change Order Creation
Correspondence with outside supplier quality teams
DHR organization and maintenance
Requirements
QUALIFICATIONS
Excellent Documentation Skills
Detail oriented and organized
Good Time Management Skills
CFR 820 and ISO 13485 knowledge preferred
Experience with an ERP and document control system
Experience with Microsoft Windows and Office Products:
Excel, Word
Must have good English written and verbal communication skills
Must be proficient in computer use
Education And Experience
Minimum of 1 year experience (proficiency test will be conducted)
Experience in Medical companies preferred
Bachelor’s Degree preferred or equivalent experience
Seniority level
Not Applicable
Employment type
Full-time
Job function
Quality Assurance
Industries
Medical Equipment Manufacturing
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Title: Quality Specialist/Document Control
Company: Astura Medical
Location: Irving, Texas, USA
Category: Quality Assurance – QA/QC (Quality Control / Manager, Quality Technician/ Inspector, QA Specialist / Manager)
