Quality Complaints Specialist

The Quality Complaints Specialist is responsible for managing and investigating product complaints to ensure timely resolution, proper documentation, and compliance with regulatory standards. The role involves interacting with customers, end-users, or healthcare professionals to address product concerns and implement corrective actions. Based in Richmond, VA, this position is open to Canadian citizens eligible for a TN visa.

Key Responsibilities:

Complaint Management:

• Manage and log incoming product complaints from customers, end-users, or healthcare professionals in a complaint management system or database.
• Ensure all complaints are accurately documented and tracked according to internal procedures and regulatory requirements.

Investigation and Resolution:

• Conduct detailed investigations into product complaints to identify root causes.
• Collaborate with cross-functional teams, including Quality, Manufacturing, and R&D, to determine corrective and preventive actions (CAPAs).
• Assess the impact of complaints on product safety, efficacy, and compliance.

Regulatory Compliance:

• Ensure complaint handling complies with applicable regulatory standards such as FDA, ISO 13485, and GMP.

• Prepare and submit complaint reports for regulatory agencies when required.

Customer Communication:

• Provide timely updates and resolutions to customers or end-users regarding the status of their complaints.
• Handle escalations professionally, ensuring customer satisfaction and alignment with company policies.

Documentation and Reporting:

• Maintain detailed records of all complaint investigations, findings, and resolutions.
• Generate periodic reports to analyze trends, identify areas for improvement, and support audits.

Training and Continuous Improvement:

• Train staff on complaint management processes and regulatory requirements.
• Identify trends in complaints and recommend process improvements to reduce future occurrences.

Qualifications:

Education:

• Bachelor’s degree in Engineering (e.g., Mechanical, Chemical, Industrial), Manufacturing, Life Sciences, or a related field.

Experience:

• 3–5 years of experience in complaint handling, quality assurance, or a related field within regulated industries such as pharmaceuticals, medical devices, or manufacturing.

Skills and Knowledge:

• Strong understanding of complaint management systems and processes.
• Knowledge of regulatory requirements (e.g., FDA, ISO 13485, GMP).
• Proficiency in root cause analysis and CAPA implementation.
• Excellent organizational, communication, and problem-solving skills.
• Familiarity with quality management systems and reporting tools.

Skills Summary:

• Core Expertise: Complaint handling, root cause analysis, CAPA implementation, regulatory compliance.
• Industry Knowledge: FDA, ISO 13485, GMP standards.
• Soft Skills: Communication, customer service, documentation, training.
• Tools: Complaint management systems, quality management tools.

The pay range that the employer in good faith reasonably expects to pay for this position is $25.43/hour - $39.73/hour. Our benefits include medical, dental, vision and retirement benefits. Applications will be accepted on an ongoing basis. Tundra Technical Solutions is among North America’s leading providers of Staffing and Consulting Services. Our success and our clients’ success are built on a foundation of service excellence. We are an equal opportunity employer, and we do not discriminate on the basis of race, religion, color, national origin, sex, sexual orientation, age, veteran status, disability, genetic information, or other applicable legally protected characteristic. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. Unincorporated LA County workers: we reasonably believe that criminal history may have a direct, adverse and negative relationship with the following job duties, potentially resulting in the withdrawal of a conditional offer of employment: client provided property, including hardware (both of which may include data) entrusted to you from theft, loss or damage; return all portable client computer hardware in your possession (including the data contained therein) upon completion of the assignment, and; maintain the confidentiality of client proprietary, confidential, or non-public information. In addition, job duties require access to secure and protected client information technology systems and related data security obligations.

Salary : $25 - $40