Sr. Quality Engineer

Senior Quality Engineer

Location: Carrollton, TX

Make a Difference in Quality and Patient Safety

We are seeking a Senior Quality Engineer with medical device industry experience to support and continuously improve our Quality Management System (QMS). In this role, you will partner with cross-functional teams to ensure compliance, drive quality excellence, and lead process improvement initiatives that support safe and effective products.

Key Responsibilities

• Lead and support quality system activities, including:
  • Nonconformances
  • CAPA investigations
  • Complaint investigations and trend analysis
  • Change control
  • Validation activities
  • Quality inspections
  • Material Review Board (MRB) activities
  • Internal audits
• Conduct root cause investigations and implement effective corrective actions.
• Collaborate with Engineering, Manufacturing, and other teams to identify and mitigate quality risks.
• Ensure compliance with FDA regulations, ISO 13485, and internal quality standards.
• Audit processes, suppliers, and materials to ensure quality requirements are met.
• Drive continuous improvement and quality enhancement projects.
• Analyze quality data and recommend process improvements.

Required Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, or a related field.
• 6+ years of Quality Engineering experience in a regulated manufacturing environment.
• Medical Device industry experience required.
• Professional quality certification (ASQ CQE, CQA, or equivalent).
• Strong knowledge of:
  • Quality Management Systems (QMS)
  • CAPA
  • Root Cause Analysis
  • Change Control
  • Validation
  • Internal Auditing
  • Complaint Handling

Preferred Qualifications

• Master's degree.
• Experience with SAP.
• Experience leading projects, teams, or continuous improvement initiatives.
• Knowledge of Lean Manufacturing or Six Sigma methodologies.
• Experience supporting regulatory audits and inspections.
  
  Additional Information
  • Ability to work non-standard hours as needed to support business objectives.
  • Commitment to maintaining a safe work environment and following all company safety policies.
  • Must be able to perform the essential functions of the position with or without reasonable accommodation.
  
  
  Salary Range: $105,300 - $115,300