Staff Quality Engineer, Complaint Handling / Post Market Surveillance #4836
GRAIL · Durham, NC · 1 wk ago
HybridQuality AssuranceFull-time
About the role
As a Staff Quality Engineer in our Research & Development - Quality & Compliance team, you will be responsible for leading the development and implementation of post-market surveillance systems to ensure product safety and efficacy. You will also oversee complaint handling processes to identify trends and improve product quality.Responsibilities
- Develop and maintain post-market surveillance systems to monitor product performance and compliance with regulatory standards.
- Oversee and analyze complaints related to product usage to identify patterns and potential issues.
- Collaborate with cross-functional teams including engineering, manufacturing, and regulatory affairs to implement corrective actions and prevent future occurrences.
- Stay updated on industry regulations and best practices in post-market surveillance and complaint handling.
Requirements
- Bachelor's degree in Engineering, Science, or a related field.
- Minimum 5 years of experience in quality assurance or related field.
- Experience with post-market surveillance systems and complaint handling processes.
- Strong analytical skills and ability to interpret data to drive improvements.
- Excellent communication and interpersonal skills to work effectively with cross-functional teams.
Qualifications
- Knowledge of FDA regulations and other relevant international standards.
- Experience with statistical analysis tools and software.
- Ability to manage multiple projects simultaneously and meet deadlines.
Skills
- Strong problem-solving and critical thinking skills.
- Proficiency in Microsoft Office Suite.
- Experience with quality management systems such as ISO 13485.
Benefits
- Competitive salary commensurate with experience.
- Flexible work schedule with remote options.
- Health insurance coverage.
- Employee assistance program.
- Professional development opportunities.