Quality Specialist Jobs

About The Position

Requirements

• High school diploma or equivalent required.
• 5–7 years of experience in Medical Device Quality Assurance required.
• Solid understanding of ISO 13485, ISO 14644, and CFR 21-820.
• Prior experience working in a clean room.
• User experience with QMS, PLM, and CMMS systems.
• Strong working knowledge of Microsoft Word and Excel.
• Strong oral, written, and interpersonal skills for interaction within the group and with other departments.
• Organizational skills and attention to detail.
• Results-oriented, with the ability to multitask.
• Self-motivated and proactive.

Nice To Haves

• Bachelor’s degree in a scientific, biomedical, or engineering discipline preferred.

Responsibilities

• Review and approve incoming inspection reports and non-conforming material reports for conformity to specifications.
• Support manufacturing operations by timely review of Device History Records (DHRs), including release of finished goods.
• Adhere to good manufacturing practices and good documentation practices.
• Participate in Corrective and Preventive Actions (CAPAs) to improve company practices and systems.
• Serve as a member of the Material Review Board for non-conforming material.
• Train Quality Inspectors on good documentation practices, standard operating procedures, and QC processes.
• Assist with internal and external audit preparation and support the Quality management team during audits.
• Promote awareness, visibility, and communication related to Quality Management System goals and initiatives.
• Perform other duties as assigned.