Job Overview: We are seeking a detail-oriented and experienced Contract Medical Device Quality Engineer to join our team. The primary responsibility of this role is to address and resolve a backlog of customer complaints related to our medical devices. This position requires a thorough understanding of regulatory requirements, quality assurance processes, and excellent analytical skills. Essential Duties and Responsibilities:
- Lead thorough investigations into customer complaints for Class I-III devices
- Ensure all complaint investigations are conducted in accordance with FDA, ISO 13485, and other applicable regulations.
- Perform detailed root cause analysis and collaborate with cross-functional teams to identify corrective and preventive actions (CAPA).
- Document and report findings in accordance with FDA regulations, ISO standards, and internal quality management systems.
- Communicate investigation results to internal stakeholders and provide recommendations for product improvements.
- Ensure timely closure of complaints and adherence to all regulatory requirements.
Minimum Qualifications:
- Bachelor's degree in Engineering, Life Sciences, or a related field.
- 3+ years of investigation experience
- 5+ years of medical device experience
- Experience working in a Lean or Six Sigma Environment
- Ability to be on-site daily