Quality Assurance Specialist
6 days ago
The Quality Engineer II will be responsible for utilizing and maintaining quality engineering systems and practices in collaboration with Agiliti manufacturing and design centers to meet and exceed internal, customer, and regulatory requirements.
Key Responsibilities- Perform quality engineering tasks for new & existing products and process development and improvement initiatives.
- Apply systematic problem-solving and SPC methodologies to identify, prioritize, communicate, and resolve quality issues.
- Develop and maintain product control plans and inspection methods for raw materials, materials in process, and final release.
- Collaborate with Design, Manufacturing, and Supply Chain teams to monitor supplier performance and detect trends.
- Lead CAPA investigations and action item implementation.
- Participate in and may lead plant Material Review Boards (MRB) to assist with investigations and disposition of product nonconformances.
- Lead review activities to maintain medical device files, resulting from engineering change orders, such as Risk Management, Process FMEA, and Quality Control Plans.
- Participate in execution of verification and validation protocols.
- Bachelor's Degree in Engineering, Scientific, or Technical related subject required.
- 3-5 years of relevant experience, preferably in a medical device manufacturing environment.
- Working knowledge in New Product development.
- Experience in FDA 21 CFR Part 820 Quality System Regulation required.
- Experience in ISO 13485:2016 Medical Devices required.
- Experience in ISO14971 Risk Management preferred, but not required.
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