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The Quality Specialist is responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards
Job Responsibility:
Complete document control transactions.
Manage Customer complaint investigations and complete complaint documentation.
Facilitate CAPA and NCR investigations and may coordinate investigation documentation.
Review DHR’s and support batch record release.
Support site inspection activities and recordkeeping.
Support supplier Quality and Customer assessment activities.
Track and trend site Quality data.
Support targeted Lean activities.
Complete other duties as assigned.
Requirements:
Two (2) years experience in a regulated industry (i.e. FDA/ISO 13485)
Customer Focused: Demonstrates a “Customer first” mindset. Responds with a sense of urgency.
Teamwork: Collaborates with others. Works in a professional manner to support team actions.
Results: Effectively manages work tasks. Is detail oriented and strives for continuous improvement. Ability to analyze technical issues. Ability to cope with change and shifting priorities.
Communication: Constructs clear written communication. Keeps manager and co-workers informed
Job Knowledge: PC experience and working familiarity of common desktop applications including Excel and Word