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. This will be a position requiring onsite presence in Forest Park, Cincinnati OH. Additionally, this position will provide support for sustaining engineering activities, including process improvements, product lifecycle management, and maintaining calibration programs.

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.

Sustaining Engineering Support

• Assist in the evaluation and implementation of changes to existing products, including design changes, material substitutions, and process modifications.
• Participate in risk assessments, including Failure Modes and Effects Analysis (FMEA).
• Support Engineering Change Orders (ECOs) and validation activities.
• Provide input on process improvements to enhance product quality and reliability.

Quality Assurance and Compliance

• Ensure all activities comply with regulatory standards, including FDA, ISO 13485, and EU MDR.
• Support internal and external audits as needed.
• Assist in maintaining the Quality Management System (QMS), including document control and training.

POSITION REQUIREMENTS

Education and Experience

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• 0-2 years of experience in the medical device, pharmaceutical, or regulated industry.

Skills and Competencies Needed

• Strong technical ability to understand the workings of devices, including mechanical parts and electronic components.
• Capability to understand technical details on device functioning and performance.
• 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.

Skills and Competencies Nice to Have

• Familiarity with root cause analysis methodologies.
• Hands-on experience with consumer hardware or medical device manufacturing or testing.
• Basic understanding of medical device regulations (e.g., FDA, ISO 13485, EU MDR).

Physical Demands

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