Quality Consultant

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.

Key Responsibilities:

Complaint Investigation:

• Review and analyze customer complaints related to medical devices.
• Conduct thorough investigations to determine the root cause of issues.
• Collaborate with cross-functional teams to gather necessary information for complaint resolution.
• Document findings and corrective actions in compliance with regulatory requirements.

Regulatory Compliance:

• Ensure all complaint investigations are conducted in accordance with FDA, ISO 13485, and other applicable regulations.
• Maintain accurate and detailed records of all complaint investigations and resolutions.

Corrective and Preventive Actions (CAPA):

• Identify trends and recurring issues from complaint data.
• Initiate and implement corrective and preventive actions to address root causes.
• Monitor the effectiveness of CAPAs to ensure issues are resolved and prevented from recurring.

Documentation and Reporting:

• Prepare detailed reports of complaint investigations and resolutions.
• Ensure all documentation is accurate, complete, and filed appropriately.
• Provide regular updates to management on the status of complaint investigations and resolutions.

Continuous Improvement:

• Recommend and implement process improvements to enhance complaint handling and resolution.
• Participate in quality audits and provide support for regulatory inspections as needed.

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• Minimum of [Insert Years] years of experience in quality assurance within the medical device industry.