Job description

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

Requirements