Quality Systems QA Engineer
2 weeks ago
Job Title: Quality Systems QA Engineer
Location: Remote
Duration: 12 Months
Work Schedule: Hybrid, Monday to Friday, 8:30 AM - 5:00 PM; Onsite as needed.
Role Overview:
The Quality Systems QA Engineer plays a pivotal role within the Quality Systems division, engaging with diverse teams across the organization. This position is essential in ensuring the effectiveness and compliance of the Quality Management System, Corrective and Preventative Actions (CAPA), and Non-conformance processes.
Key Responsibilities:
- Assist in the maintenance and enhancement of the Quality Management System.
- Facilitate continuous improvement initiatives and standardization of quality systems across various locations.
- Collaborate effectively with cross-functional teams to ensure timely completion of documentation.
- Oversee Quality Management Systems in areas such as Design Controls, Software Development, Risk Management, and CAPA.
- Support root cause analysis and the implementation of corrective actions, ensuring effectiveness is verified.
- Develop, track, and analyze key performance indicators to drive quality objectives.
- Perform additional tasks as assigned.
Preferred Qualifications:
- Bachelor's degree in a relevant field such as Sciences, Engineering, or Business.
- Experience with IVD or Medical Device Quality Systems.
- Familiarity with industry standards and regulations, including FDA QSR 820, ISO13485, ISO15189, CAP/CLIA, and IVD/IVDR.
- Understanding of CAPA processes and Root Cause Analysis.
- Knowledge of Good Manufacturing Practices.
- Strong communication skills and the ability to influence quality system processes effectively.
- Ability to thrive in a fast-paced environment with meticulous attention to detail.
- Proficiency in Microsoft Office Suite including Word, Excel, Project, and PowerPoint.
- Effective teamwork skills within a multidisciplinary setting.
- Awareness of HIPAA regulations and the significance of patient data privacy.
- Commitment to values such as patient care, innovation, collaboration, and passion.
Basic Qualifications:
- Bachelor's Degree; OR,
- 5+ years of relevant experience.
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