Quality Engineer
Job Summary : The Contract Quality Engineer will be responsible for investigating and resolving a backlog of 300 product complaints.
This role requires a hands-on approach to conduct thorough investigations, identify root causes, and implement corrective and preventive actions.
The successful candidate will work closely with cross-functional teams to ensure that all complaints are addressed in a timely and effective manner, in compliance with regulatory standards.
If you would like to know a bit more about this opportunity, or are considering applying, then please read the following job information.
Key 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.
Qualifications :
- 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.
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