2 Jobs in Nashville, TN
Tri-Imaging Solutions is Hiring a Quality Specialist Near Nashville, TN
Location: Madison, TN
Schedule: Monday- Friday 7:30am to 4:30pm (flexible)
Who We AreTri-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 OverviewWe 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 3 rd party audits.
- Training: Establish training files and conduct quality system training for company personnel to comply with quality system 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
- 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.
- Highly competitive salary
- Continuing education and training opportunities
- Company-paid holidays plus PTO
- Major medical/dental/vision coverage
- Recognition/reward program
Job Summary
Full Time
$72k-88k (estimate)
08/02/2024
08/29/2024
triimaging.com
Madison, TN
25 - 50
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The job skills required for Quality Specialist include Quality Management, ISO, Problem Solving, Microsoft Office, Internal Audit, Quality Management System, etc. Having related job skills and expertise will give you an advantage when applying to be a Quality Specialist. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Quality Specialist. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Quality Specialist positions, which can be used as a reference in future career path planning. As a Quality Specialist, it can be promoted into senior positions as a Quality Assurance Specialist III that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Quality Specialist. You can explore the career advancement for a Quality Specialist below and select your interested title to get hiring information.
If you are interested in becoming a Quality Specialist, you need to understand the job requirements and the detailed related responsibilities. Of course, a good educational background and an applicable major will also help in job hunting. Below are some tips on how to become a Quality Specialist for your reference.
Step 1: Understand the job description and responsibilities of an Accountant.
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Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.
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Step 3: View the best colleges and universities for Quality Specialist.
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