Quality Systems Engineer

Job Title: Quality Systems Engineer
Location: Memphis, TN
Duration: 6 months+

Job Summary:
Seeking a highly experienced Quality Systems Engineer with over 10 years of experience in the medical device industry. The ideal candidate will play a key role in supporting quality system improvements and ensuring compliance with industry standards.
 
Responsibilities:

• Executing action plan assignments related to audit observations and CAPAs
• Updating procedures based on ISO 13485 gap assessments,
• Driving continuous improvement initiatives such as FAI file storage enhancement, PLM system optimization, and inspection procedure refinement

 
Qualifications:

• Minimum of a bachelor’s degree is required
• 10+ years or more of medical device experience in the quality or related field
• Ability to complete action plan assignments related to audit observations and CAPA’s effectively
• Demonstrated experience in making or creating procedures, work instructions, and form templates
• The ability to manage work independently and maintain or communicate impact to project schedule are preferred
• Proficient with Microsoft Office applications, QMS and PLM