Quality Assurance Specialist
Pay: $29.00 - $34.00
The Quality Assurance Specialist will perform activities used to maintain quality processes in compliance with FDA, GMP, ISO and similar regulatory quality requirements. This position is responsible for day to day support and coordination of various Quality Systems processes, and working cross-functionally within Company to continuously improve key quality parameters. Activities include: Corrective and Preventive Actions, Document Control activities, and Manufacturing Release activities.
Essential Duties and Responsibilities:
- Non-Conforming report activities including preparation, tracking, documentation, documentation review and approval.
- Document Control activities through the electronic documentation system, including training of associates to read, review and approve documents; and maintaining a fully compliant system.
- Maintains Quality Management System records, including Device History Records, Device Master Records (DMR) and supporting documentation.
- Review of production batch records / finished goods batch records (DHR’s) for accuracy and completeness for product disposition.
- Initiate and author Deviations and Non-conformances, provide support to business owners when needed.
- Support various Change Control activities within Product & Process Design Changes, Design Transfer, Document, and Supplier portions of the Quality Management System.
- Quality warehouse functions such as periodic review of activities, process monitoring, procedure review, assistance with process improvements.
- Fosters an environment of continuous quality management improvement.
- Displays a positive, can-do attitude and assists colleagues with quality system problem identification, management and correction/prevention.
- Other duties as requested
- Bachelor’s degree in Science or Engineering.
- 1-2 years of experience in a regulated industry, preferably in the medical field.
- Experience with Quality Management Systems under GCP or CLIA.
- Experience with for ISO 9001 or ISO 13485 a plus.
- No foreign language skills required, but, German Language a plus.
- MS Office Suite skills.
- Highly organized and able to communicate effectively.
- Must be able to work independently on assigned tasks.