Quality Systems Analyst

Job Overview

The Quality Analyst / Quality Systems Lead is the Quality Systems Representative for this location. This role is responsible for ensuring that all quality-related activities are being performed according to the QMS procedures and must have a working knowledge of Quality Assurance and Quality Control.  Candidates from all industries are invited to apply.

Responsibilities:

• Quality Systems Lead and Quality Representative for the site
• Collaborate to ensure the relevance of the Quality Policy and the Quality Objectives 
• Work with Management to ensure that the proper resources are available to conduct QMS activities
• Oversee NCR, Complaint, and CAPA systems to ensure proper disposition of non-conforming materials, root cause determination, and corrective/preventive actions
• Evaluate suppliers for ability to provide needed materials/services including supplier audits
• Manage instrumentation and equipment used for inspections and V&V activities
• Maintain records needed to demonstrate conformance to the standards
• Conduct Quality Management Reviews to ensure the effectiveness of the QMS in accordance with ISO 13485 standards and applicable regulatory requirements
• Perform document control activities ensuring the most current revisions are available while segregating and storing previous revisions
• Participate in the Internal Audit program 
• Acts as a Quality Representative during external audits (customer and notified bodies)
• Promote quality as culture throughout the site and the organization 
• Work collaboratively across site functions and with all levels of the organization
• Consult on new product development projects regarding quality related questions and ensure that project documents are managed properly
• Support Verification &Validation and Design Transfer activities
• Collaborate with manufacturing/operations to develop receiving inspections, in-process inspections, and final acceptance testing for process development projects 

What your background should look like:

• Bachelor’s Degree and minimum 5 years of related work experience (Master’s Degree preferred)
• Experience working in a team environment 
• Current working knowledge of ISO 13485 Quality Management Systems and FDA 21 CFR 820 strongly preferred.
• Strong MS Excel and Word experience
• Excellent analytical skills
• Must continually seek improvement and effect change in the operating systems
• Ability to communicate effectively through email, instant messaging, and verbal methods
• Ability to work individually and in a team environment

Competencies