Complaints Coordinator

Are you looking for a great work culture, good teammates, and caring leadership? Ortho Development is the place to be. We offer great benefits, working Monday through Friday. Ortho Development Corporation helps people do what they love by restoring mobility. We are an orthopedic design, manufacturing and distribution company located in Draper, Utah. We offer a complete benefits package, clean work environment, and thorough training.

As a Complaints Coordinator plays a vital role in our post-market surveillance process, focusing on the intake, documentation, and coordination of product complaints for orthopedic implants and instruments. You will interface with multiple departments, including Quality Assurance, Regulatory Affairs, Marketing, Sales, and Engineering, to ensure that product complaints are accurately recorded, thoroughly investigated, and resolved in compliance with FDA regulations (e.g., 21 CFR Part 820) and international standards (e.g., ISO 13485). This position requires strong communication skills, exceptional attention to detail, and a collaborative approach to problem-solving.

Schedule: Monday to Friday

Location: Onsite, Draper UT

• Receive and log complaints from internal and external sources (customers, sales representatives, distributors, etc.) into the complaint management system.
• Validate the completeness and accuracy of complaint information, ensuring all relevant details, product identification, lot numbers, incident description, are documented.
• Collaborate with Quality, Engineering, Manufacturing, and Marketing teams to facilitate investigations into product complaints, gathering supporting documentation and data as needed.
• Track investigation progress and ensure timely completion, adhering to internal procedures and regulatory requirements.
• Provide additional support in root cause analysis by facilitating cross-functional communication, data collection, and testing coordination.
• Assess complaints against regulatory criteria (e.g., FDA MDR requirements) to determine whether mandatory reporting is required.
• Prepare and submit required regulatory reports (e.g., MDRs) within established timeframes.
• Maintain accurate complaint files and ensure all actions are documented and in compliance with FDA 21 CFR Part 820, ISO 13485, and other applicable regulations.
• Utilize complaint management software and other databases to track and trend complaint data (e.g., frequency, severity, failure modes).
• Prepare periodic reports for management review, highlighting notable trends or potential signals that may require further investigation or corrective action.
• Serve as the primary contact for customers and field personnel regarding complaint status, product replacements, or returns for analysis.
• Coordinate the return of suspected defective products with the appropriate teams (Quality, R&D, etc.) for evaluation and testing.
• Participate in cross-functional teams to review complaint trends, identify improvement opportunities, and implement corrective/preventive actions (CAPA).
• Recommend process or procedural enhancements to streamline complaint handling and ensure robust, compliant operations.
• Assist in developing training materials and programs related to complaint handling and documentation best practices.
• Stay updated on changing regulations and industry standards related to complaint management, sharing relevant updates with the broader QA/RA team.
• Perform other job-related duties as assigned.

• High School Diploma
• 5 years of experience in a complaint handling or post-market surveillance role within the medical device or pharmaceutical industry.
• Familiarity with orthopedic implants (knee, hip, spine, trauma) and surgical instruments is highly desirable.
• Working knowledge of FDA regulations (21 CFR Part 820), and ISO 13485.
• Complaint management systems, quality management software, and Microsoft Office Suite.
• Understanding of risk management principles (ISO 14971) and CAPA processes a plus.
• Strong communication and interpersonal skills to effectively collaborate with cross-functional teams and communicate with customers.
• Exceptional attention to detail, organizational skills, and the ability to manage multiple tasks in a fast-paced environment.
• Problem-solving mindset with a commitment to continuous improvement and maintaining high standards of compliance.

We offer competitive compensation and excellent benefits including: