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Quality Assurance Specialist
2 months ago
At NOWDiagnostics | NOWDx, we are seeking a highly skilled Quality Assurance Specialist to join our team.
Job Summary:
The Quality Assurance Specialist will work closely with the engineering group to ensure that our products comply with mandatory regulatory requirements. This includes performing reviews, creating and monitoring quality system procedures, and ensuring compliance with ISO 13485 and 21 CFR 820.
Key Responsibilities:
- Determine quality improvement factors and ensure processes adhere to quality standards.
- Prepare reports by collecting, analyzing, and summarizing data.
- Work in accordance with deadlines for delivery of products.
- Participate in root cause analysis on failures and CAPAs.
- Collect, organize, monitor, and distribute information related to supplier quality and process improvement functions.
- Ensure procedures and work instructions are documented according to corporate and ISO standards.
- Establish and implement process control plans, including capability studies and Gage R&R studies.
- Provide quality-related documents to the manufacturing floor, including control plans, control cards, visual aids, and work instructions.
- Monitor production floor processes for conformance to control plans and customer requirements.
- Develop incoming inspection processes and document incoming inspection activities.
- Track nonconforming material and lead Material Review Board (MRB) efforts.
- Interface with suppliers, contractors, and consultants that supply components, subassemblies, and contract processing.
- Lead complaint investigations on returned product.
- Ensure all quality inspections are conducted in a timely manner.
Requirements:
- Advanced proficiency in Microsoft Office products.
- Excellent communication (written and verbal) skills.
- Excellent organization skills.
- Ability to work independently and in a team environment.
Education:
- BS in Engineering (or equivalent) and a minimum of 3 years' experience in the regulated medical device industry as a Quality Assurance Engineer.
- Excellent Quality System knowledge required. Practical experience with ISO 13485, FDA Quality System Regulations, Good Manufacturing Practices, Good Documentation Practices, and other applicable standards preferred.
Note:
This job specification should not be construed to imply that these requirements are the exclusive standards of the position. Incumbents will follow any other instructions and perform any other related duties as may be required by their supervisor.
