Overview

Job Title: Quality Specialist/Sr Quality Specialist

Location: Madison, TN

Schedule: Monday- Friday 7:30am to 4:30pm (flexible)

Who We Are:

Tri-Imaging Solutions is at the forefront of medical imaging equipment innovation, specializing in enterprise imaging systems management. We're committed to pushing boundaries and delivering cutting-edge solutions to the industry. Join our dynamic team and contribute to advancing medical imaging technology.

Position Overview:

We are seeking a dedicated and detail-oriented Quality Specialist or Senior Quality Specialist to join our team. In this pivotal role, you will assist with or oversee processes and documentation related to our ISO 13485:2016 certified quality management system including quality planning, management reviews, internal audits, calibration, customer complaints, nonconformances and CAPAs, risk management, computer systems validation, document control, and supplier management. This position reports directly to the Quality Director and collaborates cross-functionally with operations, technical and field service and purchasing.

What You’ll Do:

• Quality System: On site management of the quality management system including support documentation and processes.
• Performance Reporting: Report to management on the performance of assigned aspects of the quality management system and identify areas for improvement.
• CAPA and Documentation: Evaluate and approve CAPAs, QMS documentation, customer complaints, conduct internal and external audits, validation protocols, training, NCRs, and other quality feedback mechanisms.
• Review and Compliance: Review part and service documentation and records, including test results, and handle nonconformities in parts, processes, services, and quality systems.
• Standards and Metrics: Maintain a thorough understanding of quality and documentation systems, applicable standards, and regulatory requirements. Assist with monitoring process controls and metrics to ensure compliance with ISO quality system requirements.
• Regulatory Awareness: Stay updated on applicable regulations and regulatory actions affecting the industry.
• Risk Management: Perform risk assessments as required by the QMS.
• Audits: Conduct and approve internal and supplier audits, participate in and/or host external 3rd party audits.
• Training: Establish training files and conduct quality system training for company personnel to comply with quality system requirements.

What You’ll Need (Requirements):

• Bachelor's degree in science or a related technical field.
• Minimum of 3 years in the medical device industry, with at least 2 years in a Quality role including experience working under ISO 13485:2016 requirements.
• Process management and metrics development/generation.
• Effective collaboration and communication within cross-functional teams.
• Strong prioritization skills, managing multiple projects with overlapping timelines.
• Excellent communication, decision-making, and organizational skills.
• Critical thinking and problem-solving abilities.
• Proficiency in Microsoft Office products.
• Preferred skills:
  • Candidates with Auditing certification (CQA, ISO, CBA) Candidates with eQMS experience
  • Candidates with organizational training experience
  • Candidates with Radiation Safety certification or organizational radiation safety management
  • Candidates who have prior experience managing a calibration program

Working Conditions:

• Fast-paced environment requiring strong multitasking abilities.
• Involvement in various projects and quality management tasks across different departments.
• Opportunities for professional growth and development in a dynamic industry.

What’s in It for You (Benefits):

• Highly competitive salary
• Continuing education and training opportunities
• Company-paid holidays plus PTO
• Major medical/dental/vision coverage
• Recognition/reward program