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Quality Assurance Manager
2 weeks ago
Job Description
At Xodus Medical, we are committed to patient safety in the Operating Room. We are seeking a highly skilled Quality Specialist to join our team.
Primary Responsibilities:
- Support Quality Management Systems Operations within the organization
- Track, document, and report any changes in, or improvements to, the Quality System
- Involvement in quality processes, products, device history records, inspection, and personnel in all production areas regularly to ensure compliance
- Perform trend analysis on production and field data
- Investigate and document any problems relating to the product, process, or Quality System
- Initiate, recommend, and provide solutions to quality system
- Create or modify existing procedures used in the production facility
- Create and track change notifications on changes made to the system
- Inform and influence workers on improvements and corrections
- Participate in audits from regulatory bodies and customers
- Participate in internal auditing practices
- Other Quality System related duties as assigned by Management
Requirements:
- Four year bachelor's degree from an accredited university
- Preferred minimum of 2 years of experience in a regulated medical device setting with working knowledge of FDA 21 CFR Part 820 and ISO 13485
- Required Computer Software Skills: Microsoft Office Word, Excel, PowerPoint
- Good verbal and written skills
- Ability to work in a fast-paced environment with the ability to manage multiple, simultaneous responsibilities
About Us:
Xodus Medical is a Medical Device manufacturer focusing on patient safety in the Operating Room.
