Job description 

The Senior Quality Analyst will:

• Develop and implement queries and measures to track and trend key performance indicators for processes, product, and service quality. Report on metrics and trends in accordance with internal and external regulations, policies, and procedures. Provide recommendations for the improvement of Clinisys’ Integrated Management System including processes, products, and applications. Plan and execute internal audits and perform Corrective and Preventive Actions. Provide regulatory/quality feedback to medical device design teams.

Essential Functions

• Create queries or data gathering tools to track key quality indicators using PowerBI or other application specific tools (Azure, ServiceNow).
• Collaborate with Subject Matter Experts (SMEs) and associated departments in support of process improvement/enhancement activities.
• Monitor applicable quality systems through trending analysis, compiling metrics and developing reports on a regular basis in support of improvement initiatives.
• Participate in and provide guidance to change management and product development.
• Plan and execute internal audits under ISO 13485, ISO 9001, ISO 27001, 21 CFR 820, IVDR, etc.
• All other duties and responsibilities as assigned.

Skills needed to be successful

• Analytical skills that include trending and evaluation of data with the ability to identify potential process and product improvements.
• Organizational, planning, project management and process improvement skills.
• Detailed knowledge of industry regulations and standards
• Experience with auditing, quality tools and process improvement techniques. 
• Excellent oral and written communication skills.
• Excellent problem-solving skills
• Detail Oriented

Required Experience & Education

• Bachelor’s degree or equivalent
• Proficiency with Microsoft Office
• Experience with Microsoft Azure
• 5 years quality assurance experience in a regulated industry (ISO 13485, ISO 9001, ISO 27001)
• Experience with Healthcare Software

Preferred Experience & Education

• Proficiency with writing queries in Microsoft Azure, ServiceNow, and/or other applications
• 10 years’ experience in Quality Assurance within the medical device field

Supervisory Responsibilities

• None