Complaint Handling Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Assess all incoming customer information, pinpoint, examine, and document customer complaints.

• Conduct trend analysis and maintain comprehensive records.

• Identify all customer complaints, take necessary actions, and keep accurate records.

• Report potential actionable events to the Product Safety Committee, Regulatory Affairs, and Quality Assurance.

• Manage all customer complaints within the quality management system.

• Collaborate with Customer Service, Service, Repair, Research and Development, Quality Assurance, Regulatory Affairs, and Sales to ensure necessary actions are taken.

• Undertake Corrective and Preventive Action activities as required.

• Assist with Quality Management System tasks related to customer complaints, including CAPAs, non-conformances, internal/external audits, and remediation activities.

• Support Regulatory Affairs efforts associated with customer complaints, including adverse event reporting and field actions.

• Participate in department and company-wide team meetings as necessary.

• Carry out additional duties as assigned.

• Help maintain ongoing compliance with relevant U.S. FDA, ISO 13485, and other laws, regulations, and standards.

⛳️ Requirements

• A minimum of three (3) years of hands-on experience in Quality System support activities within a U.S. FDA regulated environment.

• Extensive knowledge of U.S. FDA medical device regulations (21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807).

• In-depth understanding of international medical device standard requirements (ISO 13485/ISO 9001, ISO 14971, EU Medical Device Directive, and Canada Medical Device Regulations).

• Bachelor’s degree is highly preferred.

• Exceptional leadership, communication, collaboration, teamwork, and interpersonal skills.

• Outstanding ability to effectively engage with staff members and business partners at all organizational levels (both internal and external).

• Proficient computer and internet research skills.

• Strong capability to multi-task and meet business deadlines.

• Excellent organizational skills with a proactive mindset and the ability to prioritize tasks effectively.

• Capacity to sit for 75-100% of applicable work time.

• Ability to use hands and fingers to feel and manipulate items, including keyboards, for up to 100% of applicable work time.

• Capability to stand, talk, and hear for 75% of applicable work time.

• Ability to lift and carry up to ten pounds for up to 20% of applicable work time.

• Close vision: the ability to see clearly at twenty inches or less.

• Occasional travel (up to 25%) may be required based on business needs.

• Must adhere to relevant U.S. FDA medical device regulatory requirements, ISO 13485 requirements, and other applicable laws, regulations, and standards.

🏝️ Benefits

• 8% bonus opportunity.

• Medical, Dental, Vision coverage.

• Life Insurance.

• 401k plan.

• Paid Time Off.

• Flexible work environment.

• Reasonable accommodation in the application and selection process.