Quality Assurance Specialist
4 weeks ago
At STERIS, we strive to create a healthier and safer world by providing innovative healthcare and life science solutions. As a Quality Assurance Specialist, you will play a crucial role in ensuring our products and services meet the highest standards of quality and regulatory compliance.
Key Responsibilities:
- Assist in the administration of the quality management system to ensure adherence to ISO 9001, ISO 13485, and other applicable regulatory standards.
- Lead complaint/CAPA investigations, supplier quality improvement initiatives, and continuous improvement activities.
- Coordinate and perform problem-solving investigations, pre-reviews, and final acceptance/run release of processing runs that contain non-conformances.
- Support production and quality operations by ensuring all product processing requirements are met in accordance with customer specifications.
Requirements:
- Bachelor's Degree.
- 1-5 years of combined manufacturing/quality engineering and/or quality systems experience.
- 1-5 years of experience working in an ISO certified environment.
Preferred Experience:
- Working knowledge of FDA QSR/EUGMP regulations.
- 1-5 years of experience with medical device or other regulated industries.
Skills:
- Excellent problem-solving skills.
- Focus on identification of potential issues and continuous improvement.
- Experience working on cross-functional teams and on own initiative.
- Demonstrated excellent organizational, oral, and written communications skills.
Work Schedule:
- This is an onsite schedule position.
- 5% - 10% international and domestic travel.
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