Quality Assurance Analyst I

Job title - Quality Assurance Analyst I

Location - Houston, TX 77054 - 100% onsite role

Duration - 12 months contract

Request id# 3444-1

Job Description:

This role will be responsible for maintaining the integrity and efficiency of our Quality Management System, ensuring compliance with industry standards, and facilitating various audit processes. The ideal candidate will have strong project management skills and a keen eye for detail.

The role is that of an admin that will be processing requests from various departments. Looking for someone with a college degree or experience in medical devices or a regulated industry.

Qualifications:

• Bachelor's degree in a related field or equivalent experience.
• Proven experience in quality management systems or related administrative roles.
• Strong organizational skills and attention to detail.
• Proficiency in document management systems and electronic tracking tools.
• Excellent communication and interpersonal skills.
• Ability to coordinate multiple tasks and manage timelines effectively.
  
  

Preferred Skills:

• Familiarity with regulatory compliance standards and quality assurance processes.
• Experience in audit preparation and coordination.
• Knowledge of training management systems and instructional design principles.
  
  

Key Responsibilities:

Compliance Audits:

• Create and modify the compliance audit schedule, including preparation of agendas and checklists.
• Input audit findings into the electronic tracking system for ongoing monitoring and reporting.
  
  

Logistics Coordination:

• Coordinate logistics for outside audits, including room scheduling and facilitating Subject Matter Expert (SME) meetings.
• Organize and maintain documentation for audits, follow up on action items, and manage site communication to ensure all stakeholders are informed.
  
  

Documentation Management:

• Create and maintain an updated list of site SMEs and document matrices to ensure quick access to necessary information.
• Issue Validation numbers and manage document control change processes, including revising document ownership as requested and overseeing periodic reviews.
  
  

Management Review Coordination:

• Prepare and coordinate Management Review slides, ensuring all necessary information is presented accurately and timely.
• Follow up on action items resulting from Management Reviews to ensure accountability and completion.
  
  

Vendor Relations:

• Manage correspondence with vendors requiring controlled copies of drawings and ensure compliance with document control procedures.
  
  

Training Management:

• Process training forms, including extension requests and curriculum revisions, and initiate periodic reviews to ensure training materials are current and effective.
• Oversee the management of the Alon Houston intranet training page, ensuring it remains updated and accessible for all employees.