Quality Systems Specialist

Brief Description

The Quality Systems Specialist develops, implements and maintains quality management procedures in compliance with all relevant standards and regulations for primarily US Class I and II medical device and device accessories. The role manages site audits, analyzes data, and drives continuous improvement initiatives. They work closely with other departments to ensure that quality systems are properly integrated and maintained, implement corrective actions and preventive actions, and addresses customer feedback and complaints. They may provide quality management system training for the organization.

Essential Functions

• Act at the Management Representative for the site’s Quality Management System (QMS)
• Ensure that the processes needed for the QMS are documented
• Report to top management on the effectiveness of the QMS and any need for improvement
• Ensure promotion and awareness of applicable regulatory requirements and quality management system requirements throughout the organization
• Management Review
• Coordinate and conduct Management Reviews with the company’s Top Management to evaluate the suitability and adequacy of the site’s QMS
• Audit Management
• Plan and support Internal and External audits at the site.
• Coordinate and conduct (as needed) internal audits.
• Analysis of Data
• Develop metrics and perform trend analysis to monitor the performance of process and products
• Identify areas for improvement, corrective action, adjustment to risk files, etc.
• Customer Feedback & Complaints
• Review customer issues/complaints
• Follow up with initial reporters for additional complaint information as required
• Ensure timely processing of complaints including medical device reporting decision trees and complaint investigations within required timeframes
• Collaborate with other departments, as applicable, during complaint investigations
• Communicate any adverse events/reportable incidents to the Regulatory Compliance Specialist and Director.
• Corrective and Preventive Actions
• Define the problem, contain the problem, identify the root cause, and determine the corrective action plan
• Liaise with other departments as applicable to the issues
• Update risk files as needed.
• Provide support and guidance (as needed) to site quality activities of
• Final Inspection
• Nonconforming Product
• Returned Material Authorizations
• Receiving Inspection
• Purchasing controls
• Design controls
• Risk Management
• Other tasks and responsibilities as assigned. This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.
• Follow safety procedures and maintain a clean and safe work environment.
  
  

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Requirements

• Bachelor’s degree required. Preferably in Quality Management, Engineering or a related field preferred.
• Minimum of 3 years’ experience in Quality Management roles. Preferably in the medical device industry. (Note experience may offset degree in appropriate circumstances)
• Ability to travel independently up to 15% (domestic – to company locations).
• Ability to perform detailed tasks with accuracy.
• Excellent writing, verbal communication and listening skills with strong skills in MS Office applications.
• Familiarity with electronic quality management systems (such as Grand Avenue)
• Ability to manage multiple projects in parallel with shifting priorities.
• Critical and analytical thinking skills to enable asking follow-up questions and looking deeply into areas of concern to solve problems.
• Knowledge of Root Cause Analysis tools (training may be provided)
• Knowledge of Risk Analysis (training may be provided)
• Knowledge of Auditing techniques (training may be provided)
• Ability to work independently and productively with minimal direction and comfortable working without clear operating procedures in some situations.
• Exercise initiative by taking ownership of your decision-making skills and proactively get things done.
  
  

Summary

Beyond pay, our market-leading benefits are designed to support your wellbeing. These include medical, dental, vision, and life insurance, as well as short- and long-term disability coverage. We also provide a health savings account with company match, a retirement plan with employer contributions through Vanguard, and access to the Granite Assistance Fund for support when it’s needed most. We value time for rest and personal growth, offering generous paid time off, including volunteer time off and paid holidays.