The primary focus of this role is conducting complaint investigations of medical devices to determine root cause and ensure compliance with regulatory requirements and company quality standards. Additionally, this position will be responsible for maintaining calibration programs. This will be a position requiring onsite presence in Forest Park, Cincinnati OH.

PRIMARY RESPONSIBILITIES

Complaint Investigations

• Conduct investigations of customer complaints to identify root causes and potential product or process issues.
• Collaborate with cross-functional teams (e.g., manufacturing, R&D) to troubleshoot and resolve complaints effectively.
• Document investigation findings, corrective actions, and recommendations in accordance with regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485).
• Prepare complaint trend analysis reports and present findings to the company.
• Support communication with regulatory agencies as required (e.g., MedWatch, vigilance reporting).
• Conduct limited travel to suppliers to troubleshoot quality issues associated with complaints

Calibration and Equipment Maintenance

• Oversee and maintain the facilities calibration program to ensure all equipment is compliant and meets regulatory requirements.
• Coordinate with internal teams and external vendors to perform regular calibration of tools and equipment.
• Maintain accurate records of calibration activities in the Quality Management System (QMS).
• Troubleshoot calibration-related issues and recommend corrective actions as needed.

POSITION REQUIREMENTS

Education and Experience

• High school Diploma
• 2-5 years of experience in the medical device, pharmaceutical, or regulated industry
• Nice to have an Associate's degree in technical field

Skills and Competencies Needed

• Strong technical ability to understand the workings of devices, including mechanical parts and electronic components
• Strong analytical and problem-solving skills
• Proficiency in Microsoft Office suite
• Excellent verbal and written communication skills
• Ability to work independently and as part of a team

Physical Demands

• Ability to work in a laboratory environment
• Occasionally required to lift and move objects weighing up to 25 pounds