Quality Engineer - Katalyst Healthcares & Life Sciences
Greater Boston, MA 02203
About the Job
Responsibilities:
- Conduct in-depth investigations into product complaints, identifying root causes and determining the scope of the issue.
- Develop and implement corrective and preventive actions (CAPAs) to address identified root causes and prevent recurrence.
- Collaborate with cross-functional teams, including R&D, Manufacturing, and Regulatory Affairs, to ensure comprehensive resolution of complaints.
- Document findings, investigations, and actions taken in compliance with company and regulatory requirements.
- Prioritize and manage the complaint backlog, ensuring timely and accurate completion of investigations.
- Monitor the effectiveness of implemented solutions and make necessary adjustments to ensure continuous improvement.
- Prepare and present detailed reports on investigation outcomes and progress towards backlog elimination.
- Ensure compliance with all relevant FDA and ISO standards throughout the complaint investigation process.
- Bachelor's degree in Engineering, Biomedical Engineering, or a related field.
- 5+ years of experience in quality engineering, preferably in the medical device industry.
- Proven experience in complaint handling, root cause analysis, and CAPA development.
- Strong understanding of FDA regulations, ISO 13485, and other relevant quality standards.
Source : Katalyst Healthcares & Life Sciences
