Complaint Investigator

Responsibilities

• Process complaints using good documentation practices (GDP).
• Interface with Customer Service, Field team, and customers to gather additional information.
• Interact with customers verbally or in writing using clear, effective communication.
• Conduct investigations and provide data to drive corrective and preventive actions.
• Manage and assess incoming complaints and elevate potential issues/incidents to Quality Management/supervisor.
• Review compliant files for completeness and follow-up with suppliers (responsible party) as applicable for investigation outcomes.
• Work closely with Manufacturing, Operations, R&D and other departments to ensure quality products and processes.
• Utilize systems for the identification, analysis, correction, and prevention of quality issues.
• Create/gather, analyze, and provide feedback on complaint data for the team and management.
• Prepare final correspondence summarizing investigation findings.
• Perform queries to provide complaint data and ad hoc trend analysis.
• Provide follow-up to internal and external customers needed, including customer correspondence and regulatory agency correspondence.
• Aid in the preparation of data for internal audits and external audits/inspections.
• Adhere to all company policies, procedures, and business ethics codes.

Qualifications

• Bachelor’s degree in science or related discipline; relevant education and experience accepted in lieu of degree.
• 1+ years relevant or similar experience.
• Must be able to demonstrate ability to understand the medical device product and its application.
• Preferred knowledge of FDA Medical Device Reporting and Quality System Regulation (21 CFR Part 803, 806, and 820), and ISO Standards (ISO 13485-QMS, ISO 14971-Risk Management), as they relate to complaint investigations or equivalent.
• Proficient computer skills and knowledge of relevant business applications, Microsoft Office applications.
• Ability to learn other software quickly as required.
• Must be detail oriented. Decision making is required in balancing priorities amongst other ongoing tasks and being responsive to critical situations.
• Critical thinking and strong problem-solving skills.
• Effective verbal and interpersonal skills.
• Demonstrates good judgement in selecting methods and techniques for obtaining solutions.
• Role model for other team members.
• Strong knowledge of the product and investigation requirements. Assists other levels with building up their technical capabilities.
• Able to communicate verbally and in writing, and to receive and understand verbal and written instructions in English.
• Able to work effectively both independently and in a collaborative team environment.

Pay

The anticipated range for this position is an hourly rate of $24.00 to $35.00. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, experience and location.

Schedule

The regular hours for this full-time position are 8:00 a.m. to 5:00 p.m., Monday–Friday, unless otherwise stated by the department manager. Holiday, weekend, and evening work hours may be required. Regular hours may vary due to the needs of the organization or department and are subject to change at any time at the Company’s discretion.